A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00528372

Enrollment

1067

Registered

2007-09-12

Start date

2007-09-30

Completion date

2010-07-31

Last updated

2015-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Brief summary

The purpose of this clinical research study is to determine whether dapagliflozin can improve (decrease) blood glucose values in patients with Type 2 diabetes who have never been treated with medication or have been taking medication for less than 24 weeks since their original diabetes diagnosis. The safety of this treatment will also be studied.

Detailed description

All eligible participants will receive single-blind placebo medication during the 2-week lead-in period. All participants may receive additional open-label treatment with metformin, 500-2000 mg, as needed for rescue, based on protocol specific criteria.

Interventions

DRUGDapagliflozin

Tablets; oral; 2.5, 5.0, or 10 mg; once daily in the morning or evening for up to 102 weeks

DRUGDapagliflozin placebo

Tablets, oral, 0 mg, once daily in the morning or evening for up to 102 weeks

DRUGMetformin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 77 Years

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria * Males and females, aged 18 to 77 years * Type 2 diabetes with inadequate glycemic control, defined as: Group 1, hemoglobin A1c (HbA1c) ≥7% and ≤10%; Group 2, HbA1c ≥10.1% and ≤12.0% * Drug naive, defined as never having received prescription medications for diabetes, having received prescription medications for diabetes for \<24 weeks since the original diagnosis * C-peptide ≥1.0 ng/mL at enrollment * Body Mass Index ≤ 45.0 kg/m\^2 at enrollment Key

Exclusion criteria

* Urine albumin:creatinine ratio \>1,800 mg/g * Aspartate aminotransferase \>3\*upper limit of normal (ULN) * Alanine aminotransferase \>3\*ULN * Serum total bilirubin \>2\*ULN * Serum creatinine ≥1.5 mg/dL for men; ≥1.4 mg/dLfor women * Calcium value outside of the central laboratory normal reference range * Positive hepatitis B surface antigen * Positive anti-hepatitis C virus antibody * Hemoglobin ≤11 g/dL for men; hemoglobin ≤10 g/dL for women * Creatine kinase \>3\*ULN * Abnormal free T4 values * History of diabetes insipidus * Symptoms of poorly controlled diabetes, including marked polyuria and polydipsia with greater than 10% weight loss in the 3 months prior to enrollment * History of diabetic ketoacidosis or hyperosmolar nonketotic coma * Severe uncontrolled hypertension defined as systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg * Any of the following within 6 months of enrollment: Myocardial infarction, cardiac surgery or revascularization, unstable angina, unstable congestive heart failure (CHF), CHF New York Heart Association Class III or IV status, transient ischemic attack or significant cerebrovascular disease, unstable or previously undiagnosed arrhythmia * History of unstable or rapidly progressing renal disease * Conditions of congenital renal glucosuria * Significant hepatic disease, including chronic active hepatitis and/or severe hepatic insufficiency * Documented history of hepatotoxicity with any medication * Documented history of severe hepatobiliary disease * History of hemoglobinopathy, with the exception of sickle cell trait, thalassemia minor, or chronic or recurrent hemolysis * Donation of blood or blood products to a blood bank, blood transfusion, or participation in a clinical study requiring withdrawal of \>400 mL of blood during the 6 weeks prior to enrollment * Malignancy (with the exception of treated basal cell or treated squamous cell carcinoma) within 5 years of enrollment visit * Known immunocompromised status, including individuals who had undergone organ transplantation or who had positive HIV results * Administration of any antidiabetic therapy for more than 14 days (consecutive or not) during the 12 weeks prior to enrollment * Administration of any antidiabetic therapy, other than any previously specified, at any dose, at any time during the 4 weeks prior to enrollment * Replacement or chronic systemic corticosteroid therapy, defined as any dose of systemic corticosteroid taken for \>4 weeks within 3 months prior to enrollment * History of bariatric surgery or lap-band procedure * Administration of sibutramine, phentermine, orlistat, rimonabant, benzphetamine, diethylpropion, methamphetamine, and/or phendimetrazine, within 30 days of enrollment

Design outcomes

Primary

Measure	Time frame	Description
Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1C (HbA1c) (Last Observation Carried Forward [LOCF]): Group 1	Baseline to Week 24 (end of Short-term Period)	HbA1c was measured by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, the last postbaseline measurement prior to Week 24 was used. For rescued participants, measurements obtained after initiation of rescue medication were not considered in calculating the primary endpoint. Evening dosing groups were summarized as exploratory endpoints.
Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) (Last Observation Carried Forward [LOCF]): Group 2	Baseline to Week 24 (end of Short-term Period)	HbA1c was measured by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, the last postbaseline measurement prior to Week 24 was used. For rescued participants, measurements obtained after initiation of rescue medication were not considered in calculating the primary endpoint. Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.

Secondary

Measure	Time frame	Description
Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 1	From Baseline to Week 24 (end of Short-term Period)	Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined). Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 2	From Baseline to Week 24 (end of Short-term Period)	Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined). Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.
Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 1	Baseline to Week 1 (end of Short-term Period)	Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 2	Baseline to Week 1	Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.
Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1c] <7.0%) at Week 24 (Last Observation Carried Forward [LOCF])	Baseline to Week 24 (end of Short-term Period)	Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Therapeutic glycemic response is defined as HbA1c \<7.0%. Data after rescue medication was excluded from this analysis. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.
Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) in Patients With Baseline HbA1c ≥9.0% (Last Observation Carried Forward [LOCF])	Baseline to Week 24 (end of Short-term Period)	Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. HbA1c was measured as % of hemoglobin by a central laboratory. The population included randomized patients who received treatment and had baseline HbA1c \>9.0%. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of double-blind study drug. In cases where time of the first dose or assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study drug. Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered exploratory, included to obtain initial data. No comparator arm was included. Thus, only key safety and efficacy analyses were performed in Group 2.
Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 1	Baseline to Week 24 (end of Short-term Period)	Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized in secondary efficacy analyses. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, glucose levels were recorded from the last postbaseline measurement prior to Week 24. For rescued participants, measurements obtained after initiation of rescue medication was not considered in calculating the endpoint.
Adjusted Percentage of Participants Who Achieved Hemoglobin A1c [HbA1c] ≤6.5% (Last Observation Carried Forward [LOCF])	Baseline to Week 24 (end of Short-term Period)	Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.
Adjusted Mean Change From Baseline to Week 24 in Total Body Weight in Patients With Baseline Body Mass Index ≥27 kg/m^2 (Last Observation Carried Forward)	Baseline to Week 24 (end of Short-term Period)	Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available) was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.
Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	Day 1 to Week 102 (end of Long-term Period) + 30 days	AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or missing relationship to study drug. Includes non-SAEs and hypoglycemia with onset on or after the first date/time of double-blind treatment and on or prior to the last day of short-term plus long-term treatment plus 4 days. Includes SAEs with onset on or after the first date/time of double-blind treatment and on or prior to the last day of short-term plus long-term treatment plus 30 days.
Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Baseline to Week 102 (end of Long-term Period)	Baseline was defined as the last assessment prior to the start of the first dose of the double-blind study medication. Data included from baseline up to and including the last day of treatment plus 4 days. Data after rescue were also included. ULN=upper limit of normal; preRX=pretreatment. Phosphorus, inorganic (high) defined as \>=5.6 mg/dL for ages 17-65 years or \>=5.1 mg/dL for ages \>=66.
Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	Day 1 to Week 102 (end of Long-term Period)	Data after rescue was included. AST=aspartate aminotransferase; ALT=alanine aminotransferase; ALP=alkaline phosphatase. Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.
Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline to Week 24 (end of Short-term Period)	12-Lead ECGs were performed at entry into lead-in period Day -7 visit and Week 24/end of treatment visit (LOCF) on participants who were supine. ECGs were assessed by the investigator. Baseline was Day -7 for this parameter, and data after rescue were included.The Week 102 value is the last observation, regardless of rescue prior to Week 102 if no Week 102 measurement was available. Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])	Baseline to Week 24 (end of Short-term Period)	Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.
Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 2	Baseline to Week 24 (end of Short-term Period)	Group 2 was an exploratory group, included to obtain initial efficacy and safety data. No comparator arm was included. Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, glucose levels were recorded from the last postbaseline measurement prior to Week 24. For rescued participants, measurements obtained after initiation of rescue medication was not considered in calculating the endpoint.

Countries

Canada, Mexico, Russia, United States

Participant flow

Pre-assignment details

Of 1067 participants enrolled, 558 received treatment in the Short-term Period. Of those 558 participants, 469 entered the Long-term Period.

Participants by arm

Arm	Count
Group 1: Dapagliflozin Placebo AM & PM Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	75
Group 1: Dapagliflozin, 2.5 mg AM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	65
Group 1: Dapagliflozin, 5 mg AM Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	64
Group 1: Dapagliflozin, 10 mg AM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	70
Group 1: Dapagliflozin, 2.5 mg PM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	67
Group 1: Dapagliflozin, 5 mg PM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	68
Group 1: Dapagliflozin, 10 mg PM Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	76
Group 2: Dapagliflozin, 5 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	34
Group 2: Dapagliflozin, 10 mg AM Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.	39
Total	558

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006	FG007	FG008
Long-term (LT) Period (Weeks 24-102)	Administrative reason by sponsor	0	1	0	0	0	0	1	0	1
Long-term (LT) Period (Weeks 24-102)	Adverse Event	3	1	1	0	2	3	4	0	0
Long-term (LT) Period (Weeks 24-102)	Lack of Efficacy	6	6	1	7	7	7	2	0	0
Long-term (LT) Period (Weeks 24-102)	Lost to Follow-up	3	2	1	1	0	4	2	3	1
Long-term (LT) Period (Weeks 24-102)	No longer met study criteria	0	0	0	0	2	1	0	0	0
Long-term (LT) Period (Weeks 24-102)	Other	2	2	1	2	3	0	3	1	0
Long-term (LT) Period (Weeks 24-102)	Poor compliance or noncompliance	0	1	1	1	0	0	1	0	0
Long-term (LT) Period (Weeks 24-102)	Withdrawal by Subject	6	6	3	3	7	0	4	2	4
Short-term (ST) Period (Day 1-Week 24)	Administration reason by sponsor	1	0	1	0	0	1	0	0	0
Short-term (ST) Period (Day 1-Week 24)	Adverse Event	0	2	2	6	0	3	3	0	0
Short-term (ST) Period (Day 1-Week 24)	Lack of Efficacy	2	0	0	0	0	0	0	0	0
Short-term (ST) Period (Day 1-Week 24)	Lost to Follow-up	5	1	2	3	3	2	2	3	1
Short-term (ST) Period (Day 1-Week 24)	Other	3	0	0	1	0	0	0	1	0
Short-term (ST) Period (Day 1-Week 24)	Poor or noncompliance	0	0	0	2	0	1	0	0	0
Short-term (ST) Period (Day 1-Week 24)	Withdrawal by Subject	1	2	7	1	6	4	6	2	4

Baseline characteristics

Characteristic	Total	Group 1: Dapagliflozin Placebo AM & PM	Group 1: Dapagliflozin, 2.5 mg AM	Group 1: Dapagliflozin, 5 mg AM	Group 1: Dapagliflozin, 10 mg AM	Group 1: Dapagliflozin, 2.5 mg PM	Group 1: Dapagliflozin, 5 mg PM	Group 1: Dapagliflozin, 10 mg PM	Group 2: Dapagliflozin, 5 mg AM	Group 2: Dapagliflozin, 10 mg AM
Age, Customized ≥65 and <75	66 Participants	8 Participants	11 Participants	10 Participants	4 Participants	15 Participants	12 Participants	4 Participants	0 Participants	2 Participants
Age, Customized <65 years	487 Participants	66 Participants	54 Participants	54 Participants	66 Participants	52 Participants	53 Participants	72 Participants	34 Participants	36 Participants
Age, Customized ≥75	5 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants	0 Participants	1 Participants
Race/Ethnicity, Customized American Indian/Alaskan Native	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Asian	12 Participants	2 Participants	2 Participants	1 Participants	3 Participants	1 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Race/Ethnicity, Customized Black/African American	10 Participants	2 Participants	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants	2 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized Native Hawaiian/Other Pacific Islanders	3 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized Not reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Other	2 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized White	529 Participants	71 Participants	63 Participants	61 Participants	63 Participants	65 Participants	65 Participants	72 Participants	31 Participants	38 Participants
Sex: Female, Male Female	282 Participants	44 Participants	29 Participants	33 Participants	36 Participants	38 Participants	39 Participants	37 Participants	10 Participants	16 Participants
Sex: Female, Male Male	276 Participants	31 Participants	36 Participants	31 Participants	34 Participants	29 Participants	29 Participants	39 Participants	24 Participants	23 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	40 / 75	40 / 65	33 / 64	41 / 70	38 / 67	39 / 68	39 / 76
serious Total, serious adverse events	5 / 75	6 / 65	4 / 64	1 / 70	7 / 67	5 / 68	3 / 76

Outcome results

Primary

Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1C (HbA1c) (Last Observation Carried Forward [LOCF]): Group 1

HbA1c was measured by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, the last postbaseline measurement prior to Week 24 was used. For rescued participants, measurements obtained after initiation of rescue medication were not considered in calculating the primary endpoint. Evening dosing groups were summarized as exploratory endpoints.

Time frame: Baseline to Week 24 (end of Short-term Period)

Population: Randomized participants with nonmissing baseline and Week 24 LOCF values

Arm	Measure	Value (MEAN)	Dispersion
Group 1: Dapagliflozin Placebo AM & PM	Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1C (HbA1c) (Last Observation Carried Forward [LOCF]): Group 1	-0.23 Percent	Standard Error 0.1044
Group 1: Dapagliflozin, 2.5 mg AM	Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1C (HbA1c) (Last Observation Carried Forward [LOCF]): Group 1	-0.58 Percent	Standard Error 0.1107
Group 1: Dapagliflozin, 5 mg AM	Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1C (HbA1c) (Last Observation Carried Forward [LOCF]): Group 1	-0.77 Percent	Standard Error 0.1134
Group 1: Dapagliflozin, 10 mg AM	Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1C (HbA1c) (Last Observation Carried Forward [LOCF]): Group 1	-0.89 Percent	Standard Error 0.1099
Group 1: Dapagliflozin, 2.5 mg PM	Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1C (HbA1c) (Last Observation Carried Forward [LOCF]): Group 1	-0.83 Percent	Standard Error 0.1125
Group 1: Dapagliflozin, 5 mg PM	Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1C (HbA1c) (Last Observation Carried Forward [LOCF]): Group 1	-0.79 Percent	Standard Error 0.1117
Group 1: Dapagliflozin, 10 mg PM	Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1C (HbA1c) (Last Observation Carried Forward [LOCF]): Group 1	-0.79 Percent	Standard Error 0.1037

p-value: 0.0207ANCOVA

p-value: 0.0005ANCOVA

p-value: <0.0001ANCOVA

95% CI: [-0.91, -0.3]

95% CI: [-0.86, -0.26]

95% CI: [-0.85, -0.27]

Primary

Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) (Last Observation Carried Forward [LOCF]): Group 2

HbA1c was measured by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, the last postbaseline measurement prior to Week 24 was used. For rescued participants, measurements obtained after initiation of rescue medication were not considered in calculating the primary endpoint. Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.

Time frame: Baseline to Week 24 (end of Short-term Period)

Population: Randomized participants with HbA1c ≥10.1% and ≤12% at enrollment and nonmissing baseline and Week 24 LOCF values

Arm	Measure	Value (MEAN)	Dispersion
Group 1: Dapagliflozin Placebo AM & PM	Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) (Last Observation Carried Forward [LOCF]): Group 2	-2.88 Percent	Standard Deviation 1.406
Group 1: Dapagliflozin, 2.5 mg AM	Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) (Last Observation Carried Forward [LOCF]): Group 2	-2.66 Percent	Standard Deviation 1.261

Secondary

Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 1

Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.

Time frame: Baseline to Week 1 (end of Short-term Period)

Population: Randomized participants with nonmissing baseline and Week 24 LOCF values

Arm	Measure	Value (MEAN)	Dispersion
Group 1: Dapagliflozin Placebo AM & PM	Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 1	-2.4 mg/dL	Standard Error 2.885
Group 1: Dapagliflozin, 2.5 mg AM	Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 1	-2.9 mg/dL	Standard Error 3.219
Group 1: Dapagliflozin, 5 mg AM	Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 1	-16.4 mg/dL	Standard Error 3.248
Group 1: Dapagliflozin, 10 mg AM	Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 1	-16.1 mg/dL	Standard Error 3.016
Group 1: Dapagliflozin, 2.5 mg PM	Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 1	-14.4 mg/dL	Standard Error 3.086
Group 1: Dapagliflozin, 5 mg PM	Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 1	-18.6 mg/dL	Standard Error 3.219
Group 1: Dapagliflozin, 10 mg PM	Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 1	-20.3 mg/dL	Standard Error 3.088

95% CI: [-20.3, -3.7]

95% CI: [-24.7, -7.7]

95% CI: [-26.2, -9.5]

Secondary

Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 2

Time frame: Baseline to Week 1

Population: Randomized participants with HbA1c ≥10.1% and ≤12% at enrollment with nonmissing baseline and Week 24 LOCF values

Arm	Measure	Value (MEAN)	Dispersion
Group 1: Dapagliflozin Placebo AM & PM	Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 2	-54.3 mg/dL	Standard Deviation 41.9
Group 1: Dapagliflozin, 2.5 mg AM	Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 2	-74.3 mg/dL	Standard Deviation 51.09

Secondary

Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.

Time frame: Baseline to Week 24 (end of Short-term Period)

Population: Randomized participants with baseline BMI ≥27 kg/m\^2 and nonmissing baseline and Week 24 LOCF values

Arm	Measure	Value (MEAN)	Dispersion
Group 1: Dapagliflozin Placebo AM & PM	Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])	-0.21 Percent	Standard Error 0.121
Group 1: Dapagliflozin, 2.5 mg AM	Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])	-0.58 Percent	Standard Error 0.1265
Group 1: Dapagliflozin, 5 mg AM	Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])	-0.73 Percent	Standard Error 0.1267
Group 1: Dapagliflozin, 10 mg AM	Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])	-0.88 Percent	Standard Error 0.1201
Group 1: Dapagliflozin, 2.5 mg PM	Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])	-0.81 Percent	Standard Error 0.1329
Group 1: Dapagliflozin, 5 mg PM	Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])	-0.76 Percent	Standard Error 0.1255
Group 1: Dapagliflozin, 10 mg PM	Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])	-0.80 Percent	Standard Error 0.1194

95% CI: [-0.95, -0.25]

95% CI: [-0.89, -0.21]

95% CI: [-0.92, -0.25]

Secondary

Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 1

Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized in secondary efficacy analyses. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, glucose levels were recorded from the last postbaseline measurement prior to Week 24. For rescued participants, measurements obtained after initiation of rescue medication was not considered in calculating the endpoint.

Time frame: Baseline to Week 24 (end of Short-term Period)

Population: Randomized participants with nonmissing baseline and Week 24 LOCF values

Arm	Measure	Value (MEAN)	Dispersion
Group 1: Dapagliflozin Placebo AM & PM	Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 1	-4.1 mg/dL	Standard Error 3.906
Group 1: Dapagliflozin, 2.5 mg AM	Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 1	-15.2 mg/dL	Standard Error 4.196
Group 1: Dapagliflozin, 5 mg AM	Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 1	-24.1 mg/dL	Standard Error 4.298
Group 1: Dapagliflozin, 10 mg AM	Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 1	-28.8 mg/dL	Standard Error 4.046
Group 1: Dapagliflozin, 2.5 mg PM	Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 1	-25.6 mg/dL	Standard Error 4.132
Group 1: Dapagliflozin, 5 mg PM	Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 1	-27.3 mg/dL	Standard Error 4.17
Group 1: Dapagliflozin, 10 mg PM	Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 1	-29.6 mg/dL	Standard Error 3.964

p-value: 0.0007ANCOVA

p-value: <0.0001ANCOVA

95% CI: [-32.6, -10.3]

95% CI: [-34.4, -12]

95% CI: [-36.4, -14.5]

Secondary

Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 2

Group 2 was an exploratory group, included to obtain initial efficacy and safety data. No comparator arm was included. Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 24 assessment was available, glucose levels were recorded from the last postbaseline measurement prior to Week 24. For rescued participants, measurements obtained after initiation of rescue medication was not considered in calculating the endpoint.

Time frame: Baseline to Week 24 (end of Short-term Period)

Population: Randomized participants with HbA1c ≥10.1% and ≤12% at enrollment and nonmissing baseline and Week 24 LOCF values

Arm	Measure	Value (MEAN)	Dispersion
Group 1: Dapagliflozin Placebo AM & PM	Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 2	-77. mg/dL	Standard Deviation 53.39
Group 1: Dapagliflozin, 2.5 mg AM	Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 2	-84.3 mg/dL	Standard Deviation 61.01

Secondary

Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) in Patients With Baseline HbA1c ≥9.0% (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. HbA1c was measured as % of hemoglobin by a central laboratory. The population included randomized patients who received treatment and had baseline HbA1c \>9.0%. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of double-blind study drug. In cases where time of the first dose or assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study drug. Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered exploratory, included to obtain initial data. No comparator arm was included. Thus, only key safety and efficacy analyses were performed in Group 2.

Time frame: Baseline to Week 24 (end of Short-term Period)

Population: Randomized participants with nonmissing baseline and Week24 LOCF values.

Arm	Measure	Value (MEAN)	Dispersion
Group 1: Dapagliflozin Placebo AM & PM	Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) in Patients With Baseline HbA1c ≥9.0% (Last Observation Carried Forward [LOCF])	0.19 Percent	Standard Error 0.5473
Group 1: Dapagliflozin, 2.5 mg AM	Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) in Patients With Baseline HbA1c ≥9.0% (Last Observation Carried Forward [LOCF])	-1.26 Percent	Standard Error 0.4327
Group 1: Dapagliflozin, 5 mg AM	Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) in Patients With Baseline HbA1c ≥9.0% (Last Observation Carried Forward [LOCF])	-2.00 Percent	Standard Error 0.4079
Group 1: Dapagliflozin, 10 mg AM	Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) in Patients With Baseline HbA1c ≥9.0% (Last Observation Carried Forward [LOCF])	-2.04 Percent	Standard Error 0.3307
Group 1: Dapagliflozin, 2.5 mg PM	Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) in Patients With Baseline HbA1c ≥9.0% (Last Observation Carried Forward [LOCF])	-1.35 Percent	Standard Error 0.371
Group 1: Dapagliflozin, 5 mg PM	Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) in Patients With Baseline HbA1c ≥9.0% (Last Observation Carried Forward [LOCF])	-1.53 Percent	Standard Error 0.4416
Group 1: Dapagliflozin, 10 mg PM	Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) in Patients With Baseline HbA1c ≥9.0% (Last Observation Carried Forward [LOCF])	-1.21 Percent	Standard Error 0.3643

95% CI: [-3.33, -0.42]

95% CI: [-2.69, 0.16]

95% CI: [-2.06, 0.33]

Secondary

Adjusted Mean Change From Baseline to Week 24 in Total Body Weight in Patients With Baseline Body Mass Index ≥27 kg/m^2 (Last Observation Carried Forward)

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available) was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.

Time frame: Baseline to Week 24 (end of Short-term Period)

Population: Randomized participants with baseline BMI ≥27 kg/m\^2 and nonmissing baseline and Week 24 values

Arm	Measure	Value (MEAN)	Dispersion
Group 1: Dapagliflozin Placebo AM & PM	Adjusted Mean Change From Baseline to Week 24 in Total Body Weight in Patients With Baseline Body Mass Index ≥27 kg/m^2 (Last Observation Carried Forward)	-2.43 Kilograms	Standard Error 0.5063
Group 1: Dapagliflozin, 2.5 mg AM	Adjusted Mean Change From Baseline to Week 24 in Total Body Weight in Patients With Baseline Body Mass Index ≥27 kg/m^2 (Last Observation Carried Forward)	-3.43 Kilograms	Standard Error 0.5341
Group 1: Dapagliflozin, 5 mg AM	Adjusted Mean Change From Baseline to Week 24 in Total Body Weight in Patients With Baseline Body Mass Index ≥27 kg/m^2 (Last Observation Carried Forward)	-2.91 Kilograms	Standard Error 0.5357
Group 1: Dapagliflozin, 10 mg AM	Adjusted Mean Change From Baseline to Week 24 in Total Body Weight in Patients With Baseline Body Mass Index ≥27 kg/m^2 (Last Observation Carried Forward)	-3.39 Kilograms	Standard Error 0.4945
Group 1: Dapagliflozin, 2.5 mg PM	Adjusted Mean Change From Baseline to Week 24 in Total Body Weight in Patients With Baseline Body Mass Index ≥27 kg/m^2 (Last Observation Carried Forward)	-4.30 Kilograms	Standard Error 0.5388
Group 1: Dapagliflozin, 5 mg PM	Adjusted Mean Change From Baseline to Week 24 in Total Body Weight in Patients With Baseline Body Mass Index ≥27 kg/m^2 (Last Observation Carried Forward)	-3.70 Kilograms	Standard Error 0.5199
Group 1: Dapagliflozin, 10 mg PM	Adjusted Mean Change From Baseline to Week 24 in Total Body Weight in Patients With Baseline Body Mass Index ≥27 kg/m^2 (Last Observation Carried Forward)	-3.39 Kilograms	Standard Error 0.5027

95% CI: [-3.33, -0.42]

95% CI: [-2.69, 0.16]

95% CI: [-2.37, 0.44]

Secondary

Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 1

Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Because the primary focus of the entire dapagliflozin program was on morning dosing in a population with HbA1c ≥7% and ≤10%, only data on AM dosing were summarized. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined). Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.

Time frame: From Baseline to Week 24 (end of Short-term Period)

Population: Randomized participants with nonmissing baseline and Week 24 values

Arm	Measure	Value (MEAN)	Dispersion
Group 1: Dapagliflozin Placebo AM & PM	Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 1	-2.19 Kilograms	Standard Error 0.4297
Group 1: Dapagliflozin, 2.5 mg AM	Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 1	-3.25 Kilograms	Standard Error 0.4615
Group 1: Dapagliflozin, 5 mg AM	Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 1	-2.83 Kilograms	Standard Error 0.4731
Group 1: Dapagliflozin, 10 mg AM	Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 1	-3.16 Kilograms	Standard Error 0.4493
Group 1: Dapagliflozin, 2.5 mg PM	Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 1	-3.82 Kilograms	Standard Error 0.4548
Group 1: Dapagliflozin, 5 mg PM	Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 1	-3.55 Kilograms	Standard Error 0.4582
Group 1: Dapagliflozin, 10 mg PM	Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 1	-3.05 Kilograms	Standard Error 0.4329

p-value: 0.3101ANCOVA

p-value: 0.1189ANCOVA

95% CI: [-2.86, -0.41]

95% CI: [-2.6, -0.13]

95% CI: [-2.06, 0.33]

Secondary

Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 2

Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined). Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication.Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included.

Time frame: From Baseline to Week 24 (end of Short-term Period)

Population: Randomized participants with HbA1c ≥10.1% and ≤12% at enrollment nonmissing baseline and Week 24 LOCF values.

Arm	Measure	Value (MEAN)	Dispersion
Group 1: Dapagliflozin Placebo AM & PM	Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 2	-2.06 Kilograms	Standard Deviation 3.437
Group 1: Dapagliflozin, 2.5 mg AM	Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 2	-1.90 Kilograms	Standard Deviation 3.539

Secondary

Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1c] <7.0%) at Week 24 (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. Therapeutic glycemic response is defined as HbA1c \<7.0%. Data after rescue medication was excluded from this analysis. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.

Time frame: Baseline to Week 24 (end of Short-term Period)

Population: Randomized participants who had nonmissing baseline and Week 24 LOCF values

Arm	Measure	Value (NUMBER)
Group 1: Dapagliflozin Placebo AM & PM	Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1c] <7.0%) at Week 24 (Last Observation Carried Forward [LOCF])	31.6 Percentage of participants
Group 1: Dapagliflozin, 2.5 mg AM	Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1c] <7.0%) at Week 24 (Last Observation Carried Forward [LOCF])	41.3 Percentage of participants
Group 1: Dapagliflozin, 5 mg AM	Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1c] <7.0%) at Week 24 (Last Observation Carried Forward [LOCF])	44.2 Percentage of participants
Group 1: Dapagliflozin, 10 mg AM	Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1c] <7.0%) at Week 24 (Last Observation Carried Forward [LOCF])	50.8 Percentage of participants
Group 1: Dapagliflozin, 2.5 mg PM	Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1c] <7.0%) at Week 24 (Last Observation Carried Forward [LOCF])	51.4 Percentage of participants
Group 1: Dapagliflozin, 5 mg PM	Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1c] <7.0%) at Week 24 (Last Observation Carried Forward [LOCF])	44.0 Percentage of participants
Group 1: Dapagliflozin, 10 mg PM	Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1c] <7.0%) at Week 24 (Last Observation Carried Forward [LOCF])	51.6 Percentage of participants

95% CI: [4.9, 34.7]

95% CI: [-2.5, 27.3]

95% CI: [5.3, 34.5]

Secondary

Adjusted Percentage of Participants Who Achieved Hemoglobin A1c [HbA1c] ≤6.5% (Last Observation Carried Forward [LOCF])

Secondary endpoints were tested using a sequential testing procedure and are presented in hierarchical order. If no Week 24 assessment was available, HbA1c was recorded from the last postbaseline measurement prior to Week 24. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.

Time frame: Baseline to Week 24 (end of Short-term Period)

Population: Randomized participants with HbA1c values at both baseline and Week 24 (LOCF)

Arm	Measure	Value (NUMBER)
Group 1: Dapagliflozin Placebo AM & PM	Adjusted Percentage of Participants Who Achieved Hemoglobin A1c [HbA1c] ≤6.5% (Last Observation Carried Forward [LOCF])	14.5 Percentage of participants
Group 1: Dapagliflozin, 2.5 mg AM	Adjusted Percentage of Participants Who Achieved Hemoglobin A1c [HbA1c] ≤6.5% (Last Observation Carried Forward [LOCF])	27.2 Percentage of participants
Group 1: Dapagliflozin, 5 mg AM	Adjusted Percentage of Participants Who Achieved Hemoglobin A1c [HbA1c] ≤6.5% (Last Observation Carried Forward [LOCF])	26.6 Percentage of participants
Group 1: Dapagliflozin, 10 mg AM	Adjusted Percentage of Participants Who Achieved Hemoglobin A1c [HbA1c] ≤6.5% (Last Observation Carried Forward [LOCF])	23.1 Percentage of participants
Group 1: Dapagliflozin, 2.5 mg PM	Adjusted Percentage of Participants Who Achieved Hemoglobin A1c [HbA1c] ≤6.5% (Last Observation Carried Forward [LOCF])	33.4 Percentage of participants
Group 1: Dapagliflozin, 5 mg PM	Adjusted Percentage of Participants Who Achieved Hemoglobin A1c [HbA1c] ≤6.5% (Last Observation Carried Forward [LOCF])	25.8 Percentage of participants
Group 1: Dapagliflozin, 10 mg PM	Adjusted Percentage of Participants Who Achieved Hemoglobin A1c [HbA1c] ≤6.5% (Last Observation Carried Forward [LOCF])	26.0 Percentage of participants

95% CI: [5.5, 32.1]

95% CI: [-1.8, 24.4]

95% CI: [-1, 23.9]

Secondary

Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or missing relationship to study drug. Includes non-SAEs and hypoglycemia with onset on or after the first date/time of double-blind treatment and on or prior to the last day of short-term plus long-term treatment plus 4 days. Includes SAEs with onset on or after the first date/time of double-blind treatment and on or prior to the last day of short-term plus long-term treatment plus 30 days.

Time frame: Day 1 to Week 102 (end of Long-term Period) + 30 days

Population: Randomized participants who received at least 1 dose of study medication

Arm	Measure	Group	Value (NUMBER)
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 related SAE	0 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 AE	58 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	Hypoglycemia leading to discontinuation	0 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 Hypoglycemia	4 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	AE leading to discontinuation	4 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 Related AEs	15 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	SAEs leading to discontinuation	1 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	Deaths	0 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	SAEs	5 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 related SAE	0 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	SAEs	6 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	AE leading to discontinuation	4 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	Deaths	0 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 AE	48 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	Hypoglycemia leading to discontinuation	0 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 Hypoglycemia	3 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 Related AEs	13 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	SAEs leading to discontinuation	0 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	SAEs leading to discontinuation	1 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 related SAE	0 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	SAEs	4 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 Related AEs	10 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 AE	43 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 Hypoglycemia	0 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	Hypoglycemia leading to discontinuation	0 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	AE leading to discontinuation	4 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	Deaths	0 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 AE	56 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 Hypoglycemia	3 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	AE leading to discontinuation	5 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 related SAE	0 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 Related AEs	17 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	Deaths	1 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	SAEs leading to discontinuation	0 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	SAEs	1 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	Hypoglycemia leading to discontinuation	0 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	SAEs	7 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 AE	50 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 Hypoglycemia	2 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 Related AEs	19 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	Deaths	1 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 related SAE	0 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	SAEs leading to discontinuation	1 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	AE leading to discontinuation	2 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	Hypoglycemia leading to discontinuation	0 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 AE	50 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	Deaths	1 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	AE leading to discontinuation	6 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 Related AEs	18 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	SAEs	5 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	SAEs leading to discontinuation	2 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 related SAE	0 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 Hypoglycemia	0 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	Hypoglycemia leading to discontinuation	0 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	Hypoglycemia leading to discontinuation	0 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 AE	54 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	SAEs	3 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	Deaths	0 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 Related AEs	21 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 related SAE	0 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	SAEs leading to discontinuation	1 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 Hypoglycemia	2 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	AE leading to discontinuation	7 Participants
Group 2: Dapagliflozin, 5 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	Deaths	0 Participants
Group 2: Dapagliflozin, 5 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 Hypoglycemia	1 Participants
Group 2: Dapagliflozin, 5 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	AE leading to discontinuation	0 Participants
Group 2: Dapagliflozin, 5 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	SAEs	1 Participants
Group 2: Dapagliflozin, 5 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	Hypoglycemia leading to discontinuation	0 Participants
Group 2: Dapagliflozin, 5 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 related SAE	0 Participants
Group 2: Dapagliflozin, 5 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 AE	29 Participants
Group 2: Dapagliflozin, 5 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	SAEs leading to discontinuation	0 Participants
Group 2: Dapagliflozin, 5 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 Related AEs	12 Participants
Group 2: Dapagliflozin, 10 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	SAEs	0 Participants
Group 2: Dapagliflozin, 10 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 related SAE	0 Participants
Group 2: Dapagliflozin, 10 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 Related AEs	10 Participants
Group 2: Dapagliflozin, 10 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	SAEs leading to discontinuation	0 Participants
Group 2: Dapagliflozin, 10 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 Hypoglycemia	1 Participants
Group 2: Dapagliflozin, 10 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	AE leading to discontinuation	1 Participants
Group 2: Dapagliflozin, 10 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	>=1 AE	33 Participants
Group 2: Dapagliflozin, 10 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	Hypoglycemia leading to discontinuation	0 Participants
Group 2: Dapagliflozin, 10 mg AM	Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)	Deaths	0 Participants

Secondary

Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])

12-Lead ECGs were performed at entry into lead-in period Day -7 visit and Week 24/end of treatment visit (LOCF) on participants who were supine. ECGs were assessed by the investigator. Baseline was Day -7 for this parameter, and data after rescue were included.The Week 102 value is the last observation, regardless of rescue prior to Week 102 if no Week 102 measurement was available. Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.

Time frame: Baseline to Week 24 (end of Short-term Period)

Population: Randomized participants who received at least 1 dose of study medication and who had measurements available

Arm	Measure	Group	Value (NUMBER)
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Normal/Week 24: Not reported	0 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Normal/Week 24: Abnormal	6 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Normal/Week 24: Normal	38 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Abnormal/Week 24: Normal	5 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Abnormal/Week 24: Abnormal	18 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Abnormal/Week 24: Not reported	0 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Not reported/Week 24: Normal	0 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Basline: Not reported/Week 24: Abnormal	0 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Not reported/Week 24: Not reported	8 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Abnormal/Week 24: Abnormal	17 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Abnormal/Week 24: Normal	2 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Normal/Week 24: Normal	36 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Basline: Not reported/Week 24: Abnormal	0 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Not reported/Week 24: Normal	0 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Not reported/Week 24: Not reported	7 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Normal/Week 24: Not reported	0 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Normal/Week 24: Abnormal	3 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Abnormal/Week 24: Not reported	0 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Normal/Week 24: Normal	32 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Normal/Week 24: Not reported	0 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Not reported/Week 24: Not reported	13 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Abnormal/Week 24: Normal	3 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Abnormal/Week 24: Abnormal	11 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Abnormal/Week 24: Not reported	0 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Not reported/Week 24: Normal	0 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Basline: Not reported/Week 24: Abnormal	0 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Normal/Week 24: Abnormal	5 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Abnormal/Week 24: Abnormal	17 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Abnormal/Week 24: Not reported	0 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Basline: Not reported/Week 24: Abnormal	0 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Not reported/Week 24: Not reported	15 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Abnormal/Week 24: Normal	6 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Normal/Week 24: Not reported	0 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Normal/Week 24: Normal	31 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Normal/Week 24: Abnormal	1 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Not reported/Week 24: Normal	0 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Normal/Week 24: Not reported	0 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Normal/Week 24: Abnormal	3 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Basline: Not reported/Week 24: Abnormal	0 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Abnormal/Week 24: Normal	4 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Not reported/Week 24: Not reported	10 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Not reported/Week 24: Normal	0 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Abnormal/Week 24: Not reported	0 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Normal/Week 24: Normal	33 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Abnormal/Week 24: Abnormal	17 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Abnormal/Week 24: Normal	4 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Abnormal/Week 24: Abnormal	14 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Normal/Week 24: Normal	33 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Abnormal/Week 24: Not reported	0 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Not reported/Week 24: Not reported	11 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Not reported/Week 24: Normal	0 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Normal/Week 24: Abnormal	6 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Basline: Not reported/Week 24: Abnormal	0 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Normal/Week 24: Not reported	0 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Basline: Not reported/Week 24: Abnormal	0 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Not reported/Week 24: Normal	0 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Normal/Week 24: Not reported	0 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Normal/Week 24: Normal	35 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Abnormal/Week 24: Normal	10 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Normal/Week 24: Abnormal	10 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Abnormal/Week 24: Not reported	0 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Not reported/Week 24: Not reported	10 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])	Baseline: Abnormal/Week 24: Abnormal	11 Participants

Secondary

Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)

Data after rescue was included. AST=aspartate aminotransferase; ALT=alanine aminotransferase; ALP=alkaline phosphatase. Group 2 (patients with enrollment baseline HbA1c \>10% and ≤2%) was considered an exploratory group, included to obtain initial efficacy and safety data for these patients. No comparator arm was included. Thus, only key safety and efficacy analyses were performed for Group 2.

Time frame: Day 1 to Week 102 (end of Long-term Period)

Population: Randomized participants who received at least 1 dose of study medication and with laboratory test results available

Arm	Measure	Group	Value (NUMBER)
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	ALT >5*ULN (n=75, 65, 62, 70, 67, 67, 74)	0 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	AST >3*ULN (n=75, 65, 62, 70, 67, 67, 74, 34, 37))	0 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	ALP >1.5*ULN (n=75, 65, 62, 70, 67, 67, 74)	4 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	AST >5*ULN (n=75, 65, 62, 70, 67, 67, 74)	0 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	Bilirubin >2*ULN (n=75, 65, 62, 70, 67, 67, 74)	0 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	ALT >3*ULN (n=75, 65, 62, 70, 67, 67, 74)	1 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	Bilirubin >1.5 ULN (n=75, 65, 62, 70, 67, 67, 74)	2 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	AST >3*ULN (n=75, 65, 62, 70, 67, 67, 74, 34, 37))	1 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	AST >5*ULN (n=75, 65, 62, 70, 67, 67, 74)	0 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	Bilirubin >2*ULN (n=75, 65, 62, 70, 67, 67, 74)	0 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	Bilirubin >1.5 ULN (n=75, 65, 62, 70, 67, 67, 74)	0 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	ALT >5*ULN (n=75, 65, 62, 70, 67, 67, 74)	1 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	ALT >3*ULN (n=75, 65, 62, 70, 67, 67, 74)	1 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	ALP >1.5*ULN (n=75, 65, 62, 70, 67, 67, 74)	3 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	ALT >3*ULN (n=75, 65, 62, 70, 67, 67, 74)	2 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	ALP >1.5*ULN (n=75, 65, 62, 70, 67, 67, 74)	1 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	AST >5*ULN (n=75, 65, 62, 70, 67, 67, 74)	0 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	AST >3*ULN (n=75, 65, 62, 70, 67, 67, 74, 34, 37))	1 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	Bilirubin >2*ULN (n=75, 65, 62, 70, 67, 67, 74)	0 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	ALT >5*ULN (n=75, 65, 62, 70, 67, 67, 74)	0 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	Bilirubin >1.5 ULN (n=75, 65, 62, 70, 67, 67, 74)	1 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	ALT >5*ULN (n=75, 65, 62, 70, 67, 67, 74)	0 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	AST >3*ULN (n=75, 65, 62, 70, 67, 67, 74, 34, 37))	0 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	AST >5*ULN (n=75, 65, 62, 70, 67, 67, 74)	0 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	ALT >3*ULN (n=75, 65, 62, 70, 67, 67, 74)	1 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	Bilirubin >1.5 ULN (n=75, 65, 62, 70, 67, 67, 74)	0 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	Bilirubin >2*ULN (n=75, 65, 62, 70, 67, 67, 74)	0 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	ALP >1.5*ULN (n=75, 65, 62, 70, 67, 67, 74)	1 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	ALP >1.5*ULN (n=75, 65, 62, 70, 67, 67, 74)	4 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	AST >3*ULN (n=75, 65, 62, 70, 67, 67, 74, 34, 37))	5 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	ALT >5*ULN (n=75, 65, 62, 70, 67, 67, 74)	0 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	ALT >3*ULN (n=75, 65, 62, 70, 67, 67, 74)	0 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	AST >5*ULN (n=75, 65, 62, 70, 67, 67, 74)	2 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	Bilirubin >2*ULN (n=75, 65, 62, 70, 67, 67, 74)	1 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	Bilirubin >1.5 ULN (n=75, 65, 62, 70, 67, 67, 74)	2 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	ALP >1.5*ULN (n=75, 65, 62, 70, 67, 67, 74)	3 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	AST >3*ULN (n=75, 65, 62, 70, 67, 67, 74, 34, 37))	1 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	AST >5*ULN (n=75, 65, 62, 70, 67, 67, 74)	0 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	Bilirubin >1.5 ULN (n=75, 65, 62, 70, 67, 67, 74)	1 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	Bilirubin >2*ULN (n=75, 65, 62, 70, 67, 67, 74)	0 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	ALT >5*ULN (n=75, 65, 62, 70, 67, 67, 74)	0 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	ALT >3*ULN (n=75, 65, 62, 70, 67, 67, 74)	0 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	ALT >5*ULN (n=75, 65, 62, 70, 67, 67, 74)	0 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	Bilirubin >1.5 ULN (n=75, 65, 62, 70, 67, 67, 74)	0 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	AST >5*ULN (n=75, 65, 62, 70, 67, 67, 74)	0 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	Bilirubin >2*ULN (n=75, 65, 62, 70, 67, 67, 74)	0 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	AST >3*ULN (n=75, 65, 62, 70, 67, 67, 74, 34, 37))	4 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	ALP >1.5*ULN (n=75, 65, 62, 70, 67, 67, 74)	2 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)	ALT >3*ULN (n=75, 65, 62, 70, 67, 67, 74)	0 Participants

Secondary

Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)

Baseline was defined as the last assessment prior to the start of the first dose of the double-blind study medication. Data included from baseline up to and including the last day of treatment plus 4 days. Data after rescue were also included. ULN=upper limit of normal; preRX=pretreatment. Phosphorus, inorganic (high) defined as \>=5.6 mg/dL for ages 17-65 years or \>=5.1 mg/dL for ages \>=66.

Time frame: Baseline to Week 102 (end of Long-term Period)

Population: Randomized participants who received at least 1 dose of study medication and with laboratory test results available

Arm	Measure	Group	Value (NUMBER)
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Hematocrit (>55%)	0 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Glucose (<54 mg/dL)	0 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Sodium, serum (<130 mEq/L)	1 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Hemoglobin (>18 g/dL)	0 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Bicarbonate (<=13 mEq/L)	0 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Phosphorus, inorganic (high)	2 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Glucose ( >350 mg/dL)	2 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Albumin/creatinine ratio (>1800 mg/g)	0 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Calcium, total (<7.5 mg/dL)	3 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Creatinine (>=1.5 preRX creatinine)	0 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Hematocrit (>60%)	0 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Potassium, serum (>=6 mEqL)	3 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Creatine kinase (>5*ULN)	1 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Sodium, serum (>150 mEq/L)	1 Participants
Group 1: Dapagliflozin Placebo AM & PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Creatine kinase (>10*ULN)	0 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Glucose (<54 mg/dL)	0 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Bicarbonate (<=13 mEq/L)	0 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Calcium, total (<7.5 mg/dL)	0 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Creatinine (>=1.5 preRX creatinine)	1 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Hematocrit (>60%)	0 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Hematocrit (>55%)	1 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Albumin/creatinine ratio (>1800 mg/g)	1 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Hemoglobin (>18 g/dL)	3 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Phosphorus, inorganic (high)	0 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Glucose ( >350 mg/dL)	2 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Sodium, serum (>150 mEq/L)	1 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Sodium, serum (<130 mEq/L)	2 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Creatine kinase (>5*ULN)	0 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Potassium, serum (>=6 mEqL)	1 Participants
Group 1: Dapagliflozin, 2.5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Creatine kinase (>10*ULN)	0 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Glucose ( >350 mg/dL)	0 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Hemoglobin (>18 g/dL)	2 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Sodium, serum (>150 mEq/L)	0 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Bicarbonate (<=13 mEq/L)	1 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Albumin/creatinine ratio (>1800 mg/g)	0 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Glucose (<54 mg/dL)	0 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Sodium, serum (<130 mEq/L)	0 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Creatine kinase (>10*ULN)	0 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Hematocrit (>60%)	0 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Creatine kinase (>5*ULN)	0 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Potassium, serum (>=6 mEqL)	1 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Hematocrit (>55%)	0 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Phosphorus, inorganic (high)	1 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Creatinine (>=1.5 preRX creatinine)	2 Participants
Group 1: Dapagliflozin, 5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Calcium, total (<7.5 mg/dL)	0 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Glucose ( >350 mg/dL)	0 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Hematocrit (>55%)	2 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Creatine kinase (>10*ULN)	1 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Sodium, serum (>150 mEq/L)	0 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Phosphorus, inorganic (high)	0 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Creatine kinase (>5*ULN)	1 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Creatinine (>=1.5 preRX creatinine)	1 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Bicarbonate (<=13 mEq/L)	0 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Calcium, total (<7.5 mg/dL)	0 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Glucose (<54 mg/dL)	0 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Albumin/creatinine ratio (>1800 mg/g)	0 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Hematocrit (>60%)	1 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Sodium, serum (<130 mEq/L)	0 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Potassium, serum (>=6 mEqL)	2 Participants
Group 1: Dapagliflozin, 10 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Hemoglobin (>18 g/dL)	4 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Calcium, total (<7.5 mg/dL)	3 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Hematocrit (>55%)	2 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Hematocrit (>60%)	0 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Hemoglobin (>18 g/dL)	2 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Glucose ( >350 mg/dL)	0 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Glucose (<54 mg/dL)	2 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Creatine kinase (>5*ULN)	1 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Creatine kinase (>10*ULN)	1 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Bicarbonate (<=13 mEq/L)	0 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Potassium, serum (>=6 mEqL)	4 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Sodium, serum (<130 mEq/L)	0 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Sodium, serum (>150 mEq/L)	1 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Phosphorus, inorganic (high)	0 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Albumin/creatinine ratio (>1800 mg/g)	0 Participants
Group 1: Dapagliflozin, 2.5 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Creatinine (>=1.5 preRX creatinine)	1 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Sodium, serum (>150 mEq/L)	0 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Hemoglobin (>18 g/dL)	1 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Glucose ( >350 mg/dL)	0 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Bicarbonate (<=13 mEq/L)	0 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Phosphorus, inorganic (high)	3 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Hematocrit (>55%)	1 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Potassium, serum (>=6 mEqL)	1 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Creatine kinase (>5*ULN)	1 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Calcium, total (<7.5 mg/dL)	2 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Sodium, serum (<130 mEq/L)	0 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Albumin/creatinine ratio (>1800 mg/g)	0 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Glucose (<54 mg/dL)	0 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Hematocrit (>60%)	0 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Creatine kinase (>10*ULN)	1 Participants
Group 1: Dapagliflozin, 5 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Creatinine (>=1.5 preRX creatinine)	1 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Creatine kinase (>10*ULN)	1 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Hematocrit (>60%)	1 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Glucose ( >350 mg/dL)	0 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Hematocrit (>55%)	4 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Phosphorus, inorganic (high)	2 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Glucose (<54 mg/dL)	0 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Hemoglobin (>18 g/dL)	6 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Creatinine (>=1.5 preRX creatinine)	1 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Albumin/creatinine ratio (>1800 mg/g)	0 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Creatine kinase (>5*ULN)	2 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Sodium, serum (>150 mEq/L)	0 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Sodium, serum (<130 mEq/L)	1 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Potassium, serum (>=6 mEqL)	1 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Bicarbonate (<=13 mEq/L)	0 Participants
Group 1: Dapagliflozin, 10 mg PM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Calcium, total (<7.5 mg/dL)	1 Participants
Group 2: Dapagliflozin, 5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Creatine kinase (>10*ULN)	0 Participants
Group 2: Dapagliflozin, 5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Bicarbonate (<=13 mEq/L)	0 Participants
Group 2: Dapagliflozin, 5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Creatine kinase (>5*ULN)	0 Participants
Group 2: Dapagliflozin, 5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Potassium, serum (>=6 mEqL)	1 Participants
Group 2: Dapagliflozin, 5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Glucose (<54 mg/dL)	0 Participants
Group 2: Dapagliflozin, 5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Sodium, serum (<130 mEq/L)	0 Participants
Group 2: Dapagliflozin, 5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Glucose ( >350 mg/dL)	0 Participants
Group 2: Dapagliflozin, 5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Sodium, serum (>150 mEq/L)	0 Participants
Group 2: Dapagliflozin, 5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Hemoglobin (>18 g/dL)	3 Participants
Group 2: Dapagliflozin, 5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Phosphorus, inorganic (high)	0 Participants
Group 2: Dapagliflozin, 5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Hematocrit (>60%)	0 Participants
Group 2: Dapagliflozin, 5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Creatinine (>=1.5 preRX creatinine)	1 Participants
Group 2: Dapagliflozin, 5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Albumin/creatinine ratio (>1800 mg/g)	0 Participants
Group 2: Dapagliflozin, 5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Hematocrit (>55%)	2 Participants
Group 2: Dapagliflozin, 5 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Calcium, total (<7.5 mg/dL)	0 Participants
Group 2: Dapagliflozin, 10 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Glucose ( >350 mg/dL)	0 Participants
Group 2: Dapagliflozin, 10 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Calcium, total (<7.5 mg/dL)	0 Participants
Group 2: Dapagliflozin, 10 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Sodium, serum (<130 mEq/L)	1 Participants
Group 2: Dapagliflozin, 10 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Creatinine (>=1.5 preRX creatinine)	1 Participants
Group 2: Dapagliflozin, 10 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Creatine kinase (>5*ULN)	0 Participants
Group 2: Dapagliflozin, 10 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Albumin/creatinine ratio (>1800 mg/g)	0 Participants
Group 2: Dapagliflozin, 10 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Hematocrit (>55%)	4 Participants
Group 2: Dapagliflozin, 10 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Creatine kinase (>10*ULN)	0 Participants
Group 2: Dapagliflozin, 10 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Glucose (<54 mg/dL)	0 Participants
Group 2: Dapagliflozin, 10 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Hemoglobin (>18 g/dL)	5 Participants
Group 2: Dapagliflozin, 10 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Potassium, serum (>=6 mEqL)	1 Participants
Group 2: Dapagliflozin, 10 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Phosphorus, inorganic (high)	2 Participants
Group 2: Dapagliflozin, 10 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Sodium, serum (>150 mEq/L)	0 Participants
Group 2: Dapagliflozin, 10 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Hematocrit (>60%)	1 Participants
Group 2: Dapagliflozin, 10 mg AM	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)	Bicarbonate (<=13 mEq/L)	0 Participants

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026

A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1C (HbA1c) (Last Observation Carried Forward [LOCF]): Group 1

Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) (Last Observation Carried Forward [LOCF]): Group 2

Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 1

Adjusted Mean Change From Baseline in Fasting Plasma Glucose Levels at Week 1 (Last Observation Carried Forward [LOCF]): Group 2

Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF])

Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 1

Adjusted Mean Change From Baseline to Week 24 in Fasting Plasma Glucose Levels (Last Observation Carried Forward [LOCF]): Group 2

Adjusted Mean Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) in Patients With Baseline HbA1c ≥9.0% (Last Observation Carried Forward [LOCF])

Adjusted Mean Change From Baseline to Week 24 in Total Body Weight in Patients With Baseline Body Mass Index ≥27 kg/m^2 (Last Observation Carried Forward)

Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 1

Adjusted Mean Change in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]): Group 2

Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1c] <7.0%) at Week 24 (Last Observation Carried Forward [LOCF])

Adjusted Percentage of Participants Who Achieved Hemoglobin A1c [HbA1c] ≤6.5% (Last Observation Carried Forward [LOCF])

Number of Participants With Adverse Events (AE), Hypoglycemia, Related AEs, Death as Outcome, Related Serious AEs (SAEs), SAEs and AEs Leading to Discontinuation, and Hypoglycemia Leading to Discontinuation (Short-term + Long-term Periods)

Number of Participants With Changes From Baseline in Electrocardiogram (ECG) Findings (Last Observation Carried Forward {LOCF])

Number of Participants With Elevated Levels of Liver Enzymes on Laboratory Test Results (Short-term and Long-term Periods)

Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Laboratory Abnormality (Short-term and Long-term Periods)