Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide

A Randomized Trial Comparing Insulin Lispro Protamine Suspension With Insulin Glargine in Subjects With Type 2 Diabetes on Oral Antihyperglycemic Medications and Exenatide

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00560417

Enrollment

339

Registered

2007-11-19

Start date

2007-11-30

Completion date

2009-12-31

Last updated

2011-01-13

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

Conditions

Diabetes Mellitus, Type 2

Brief summary

This study will compare insulin lispro protamine suspension (ILPS) and insulin glargine in combination with the patient's oral diabetes medications and exenatide, for their ability to control blood sugar in patients with type 2 diabetes.

Interventions

DRUGInsulin Lispro Protamine Suspension

Administered subcutaneously once a day at bedtime

DRUGInsulin Glargine

Administered subcutaneously once a day at bedtime

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 74 Years

Healthy volunteers

Inclusion criteria

* Must have type 2 diabetes * Must be at least 18 years of age and less than 75 years of age * Must be taking exenatide 10 micrograms twice a day (BID) for at least 3 months * Must be taking one of the following oral diabetes medication regimens for at least 3 months: (1) metformin (2) metformin + sulfonylurea (3) metformin + thiazolidinedione (TZD). Doses must be at or above the following: Metformin--1500 mg/day, Sulfonylurea--1/2 the maximum daily dose according to the product label, TZD--30 mg/day pioglitazone * Must have a hemoglobin A1C greater than or equal to 7.0% and less than or equal to 10.0%

Exclusion criteria

* Must not have used insulin on a regular basis during the past 2 years * Must not have taken any glucose-lowering medications not included in the inclusion criteria in the past 3 months * Must not have had more than one episode of severe hypoglycemia in the past 6 months * Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease * Must not be pregnant or intend to get pregnant during the course of the study

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])	Baseline, Endpoint (LOCF) up to 24 weeks	Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline sulfonylurea (SU) Group.

Secondary

Measure	Time frame	Description
Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)	Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks	Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.
Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%	Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks	—
7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Baseline, Endpoint (LOCF) up to 24 weeks	SMBG at morning pre-meal, morning post-prandial, midday pre-meal, midday post-prandial, evening pre-meal, evening postprandial, 0300 hours. Post-prandial glucose is measured 2 hours after the start of the meal.
Glycemic Variability at Baseline and Endpoint (LOCF)	Baseline, Endpoint (LOCF) up to 24 weeks	Glycemic variability was defined as the standard deviation (SD) of a participant's intra-day 7-point, self-monitored, blood glucose. Mean SD was calculated based on the SD for each participant in the study.
Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)	24 weeks, Endpoint (LOCF) up to 24 weeks	Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.
Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)	Baseline to Endpoint (LOCF) up to 24 weeks	Rate of self-reported hypoglycemic episodes, all, non-nocturnal, and nocturnal, at Endpoint (LOCF) and overall. Rate is reported as episodes/participant/365 days. Episode = any time participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if it was not associated with signs, symptoms, or treatment. Overall=any time during the post-randomization visits within the study period. Nocturnal=Any episode that occurs between bedtime and waking. Non-Nocturnal=Any episode that occurs between waking and bedtime.
Actual Body Weight at Baseline and Endpoint (LOCF)	Baseline, Endpoint (LOCF) up to 24 weeks	—
Change From Baseline in Body Weight at Endpoint (LOCF)	Baseline, Endpoint (LOCF) up to 24 weeks	—
Total Daily Insulin Dose at Endpoint (LOCF)	Endpoint (LOCF) up to 24 weeks	—
Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)	Baseline to Endpoint (LOCF) up to 24 weeks	Overall:any time after randomization.Episode:any time patient experienced sign/symptom associated with hypoglycemia, or had blood glucose level ≤70 mg/dL. Non-nocturnal:any episode that occurred between waking and bedtime. Nocturnal:any episode that occurred between bedtime and waking.Severe:episode with symptoms consistent with neuroglycopenia in which patient requires assistance,and is associated with:blood glucose value \<50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.Incidence(%)=(Number of patients experiencing episodes/number of patients in arm)\*100.

Countries

Puerto Rico, United States

Participant flow

Pre-assignment details

Intention to Treat (ITT) Population consisted of all randomized participants who received at least one dose of study drug and had at least one post-baseline measurement.

Participants by arm

Arm	Count
ILPS Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks	171
Glargine Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks	168
Total	339

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	3	2
Overall Study	Entry Criteria Not Met	1	0
Overall Study	Lost to Follow-up	0	1
Overall Study	Physician Decision	2	6
Overall Study	Protocol Violation	6	5
Overall Study	Sponsor Decision	2	0
Overall Study	Withdrawal by Subject	3	3

Baseline characteristics

Characteristic	ILPS	Total	Glargine
Age Continuous	56.51 years STANDARD_DEVIATION 9.73	56.38 years STANDARD_DEVIATION 9.52	56.24 years STANDARD_DEVIATION 9.33
Body Mass Index	34.92 kilograms/square meters (kg/m^2) STANDARD_DEVIATION 5.21	34.85 kilograms/square meters (kg/m^2) STANDARD_DEVIATION 5.18	34.78 kilograms/square meters (kg/m^2) STANDARD_DEVIATION 5.17
Body Weight	101.57 Kilograms STANDARD_DEVIATION 18.67	101.95 Kilograms STANDARD_DEVIATION 19.18	102.33 Kilograms STANDARD_DEVIATION 19.73
Duration of Diabetes	9.51 years STANDARD_DEVIATION 5.98	9.91 years STANDARD_DEVIATION 6.31	10.31 years STANDARD_DEVIATION 6.63
Hemoglobin A1C	8.21 percent of glycosylated hemoglobin STANDARD_DEVIATION 0.79	8.22 percent of glycosylated hemoglobin STANDARD_DEVIATION 0.79	8.22 percent of glycosylated hemoglobin STANDARD_DEVIATION 0.8
Race/Ethnicity, Customized Black or African American	13 participants	27 participants	14 participants
Race/Ethnicity, Customized East Asian	5 participants	11 participants	6 participants
Race/Ethnicity, Customized Hispanic	21 participants	38 participants	17 participants
Race/Ethnicity, Customized Native American	0 participants	1 participants	1 participants
Race/Ethnicity, Customized West Asian (Indian sub-continent)	2 participants	2 participants	0 participants
Race/Ethnicity, Customized White	130 participants	260 participants	130 participants
Region of Enrollment Puerto Rico	6 participants	9 participants	3 participants
Region of Enrollment United States	165 participants	330 participants	165 participants
Sex: Female, Male Female	95 Participants	170 Participants	75 Participants
Sex: Female, Male Male	76 Participants	169 Participants	93 Participants
Sulfonylurea Group No	63 participants	121 participants	58 participants
Sulfonylurea Group Yes	108 participants	218 participants	110 participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	96 / 170	115 / 167
serious Total, serious adverse events	9 / 170	5 / 167

Outcome results

Primary

Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])

Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline sulfonylurea (SU) Group.

Time frame: Baseline, Endpoint (LOCF) up to 24 weeks

Population: All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
ILPS	Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])	Baseline	8.48 percent of glycosylated hemoglobin	Standard Error 0.04
ILPS	Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])	Endpoint (LOCF) Change	-1.21 percent of glycosylated hemoglobin	Standard Error 0.07
Glargine	Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])	Baseline	8.47 percent of glycosylated hemoglobin	Standard Error 0.04
Glargine	Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])	Endpoint (LOCF) Change	-1.43 percent of glycosylated hemoglobin	Standard Error 0.07

95% CI: [0.06, 0.38]ANCOVA

Secondary

7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)

SMBG at morning pre-meal, morning post-prandial, midday pre-meal, midday post-prandial, evening pre-meal, evening postprandial, 0300 hours. Post-prandial glucose is measured 2 hours after the start of the meal.

Time frame: Baseline, Endpoint (LOCF) up to 24 weeks

Population: All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Arm	Measure	Group	Value (MEAN)	Dispersion
ILPS	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Baseline Morning Pre-Meal	175.41 milligrams per deciliter (mg/dL)	Standard Deviation 39.54
ILPS	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Baseline Morning Postprandial	195.31 milligrams per deciliter (mg/dL)	Standard Deviation 54.65
ILPS	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Baseline Midday Pre-Meal	165.18 milligrams per deciliter (mg/dL)	Standard Deviation 43.51
ILPS	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Baseline Evening Postprandial	189.00 milligrams per deciliter (mg/dL)	Standard Deviation 49.62
ILPS	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Baseline 0300 Hours	170.51 milligrams per deciliter (mg/dL)	Standard Deviation 43.44
ILPS	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Baseline Daily Mean 7-Point Blood Glucose	180.19 milligrams per deciliter (mg/dL)	Standard Deviation 36.95
ILPS	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Baseline Daily Mean Pre-Meal	170.60 milligrams per deciliter (mg/dL)	Standard Deviation 36.06
ILPS	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Baseline Daily Mean Postprandial	192.37 milligrams per deciliter (mg/dL)	Standard Deviation 41.48
ILPS	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Endpoint Morning Pre-Meal	129.63 milligrams per deciliter (mg/dL)	Standard Deviation 31.58
ILPS	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Endpoint Morning Postprandial	152.32 milligrams per deciliter (mg/dL)	Standard Deviation 44.81
ILPS	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Endpoint Midday Pre-Meal	132.84 milligrams per deciliter (mg/dL)	Standard Deviation 36.63
ILPS	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Endpoint Midday Postprandial	161.77 milligrams per deciliter (mg/dL)	Standard Deviation 42.46
ILPS	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Endpoint Evening Pre-Meal	146.03 milligrams per deciliter (mg/dL)	Standard Deviation 37.93
ILPS	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Endpoint Evening Postprandial	159.14 milligrams per deciliter (mg/dL)	Standard Deviation 45.35
ILPS	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Endpoint 0300 Hours	123.96 milligrams per deciliter (mg/dL)	Standard Deviation 35.45
ILPS	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Endpoint Daily Mean 7-Point Blood Glucose	143.06 milligrams per deciliter (mg/dL)	Standard Deviation 30
ILPS	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Endpoint Daily Mean Pre-Meal	135.51 milligrams per deciliter (mg/dL)	Standard Deviation 30.39
ILPS	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Endpoint Daily Mean Postprandial	158.10 milligrams per deciliter (mg/dL)	Standard Deviation 36.81
ILPS	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Baseline Midday Postprandial	193.22 milligrams per deciliter (mg/dL)	Standard Deviation 46.95
ILPS	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Baseline Evening Pre-Meal	173.33 milligrams per deciliter (mg/dL)	Standard Deviation 44.6
Glargine	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Endpoint Daily Mean Postprandial	146.12 milligrams per deciliter (mg/dL)	Standard Deviation 30.37
Glargine	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Baseline Morning Pre-Meal	180.86 milligrams per deciliter (mg/dL)	Standard Deviation 38.95
Glargine	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Endpoint Midday Pre-Meal	129.71 milligrams per deciliter (mg/dL)	Standard Deviation 34.34
Glargine	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Baseline Morning Postprandial	190.84 milligrams per deciliter (mg/dL)	Standard Deviation 54.95
Glargine	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Endpoint Daily Mean 7-Point Blood Glucose	136.17 milligrams per deciliter (mg/dL)	Standard Deviation 25.65
Glargine	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Baseline Midday Pre-Meal	166.34 milligrams per deciliter (mg/dL)	Standard Deviation 47.64
Glargine	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Endpoint Midday Postprandial	155.26 milligrams per deciliter (mg/dL)	Standard Deviation 37.86
Glargine	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Baseline Evening Postprandial	184.92 milligrams per deciliter (mg/dL)	Standard Deviation 49.42
Glargine	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Baseline Evening Pre-Meal	175.14 milligrams per deciliter (mg/dL)	Standard Deviation 43.35
Glargine	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Baseline 0300 Hours	172.00 milligrams per deciliter (mg/dL)	Standard Deviation 39.1
Glargine	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Endpoint Evening Pre-Meal	135.93 milligrams per deciliter (mg/dL)	Standard Deviation 33.79
Glargine	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Baseline Daily Mean 7-Point Blood Glucose	180.72 milligrams per deciliter (mg/dL)	Standard Deviation 38.17
Glargine	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Endpoint Daily Mean Pre-Meal	129.32 milligrams per deciliter (mg/dL)	Standard Deviation 26.54
Glargine	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Baseline Daily Mean Pre-Meal	172.66 milligrams per deciliter (mg/dL)	Standard Deviation 38.6
Glargine	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Endpoint Evening Postprandial	144.25 milligrams per deciliter (mg/dL)	Standard Deviation 34.17
Glargine	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Baseline Daily Mean Postprandial	191.27 milligrams per deciliter (mg/dL)	Standard Deviation 46.11
Glargine	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Baseline Midday Postprandial	200.25 milligrams per deciliter (mg/dL)	Standard Deviation 54.64
Glargine	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Endpoint Morning Pre-Meal	127.01 milligrams per deciliter (mg/dL)	Standard Deviation 29.08
Glargine	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Endpoint 0300 Hours	127.53 milligrams per deciliter (mg/dL)	Standard Deviation 30.9
Glargine	7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)	Endpoint Morning Postprandial	137.39 milligrams per deciliter (mg/dL)	Standard Deviation 36.65

p-value: 0.17995% CI: [-1.97, 10.53]ANCOVA

p-value: <0.00195% CI: [5.72, 22.19]ANCOVA

p-value: 0.32595% CI: [-3.79, 11.39]ANCOVA

p-value: 0.05195% CI: [-0.04, 17.5]ANCOVA

p-value: 0.00395% CI: [3.66, 18.19]ANCOVA

p-value: 0.00295% CI: [5.44, 22.94]ANCOVA

p-value: 0.41595% CI: [-10.35, 4.28]ANCOVA

p-value: 0.01595% CI: [1.46, 13.32]ANCOVA

p-value: 0.02195% CI: [1.1, 13.14]ANCOVA

p-value: <0.00195% CI: [5.01, 18.93]ANCOVA

Secondary

Actual Body Weight at Baseline and Endpoint (LOCF)

Time frame: Baseline, Endpoint (LOCF) up to 24 weeks

Population: All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Arm	Measure	Group	Value (MEAN)	Dispersion
ILPS	Actual Body Weight at Baseline and Endpoint (LOCF)	Baseline	101.57 kilograms	Standard Deviation 18.67
ILPS	Actual Body Weight at Baseline and Endpoint (LOCF)	Endpoint	101.85 kilograms	Standard Deviation 18.91
Glargine	Actual Body Weight at Baseline and Endpoint (LOCF)	Baseline	102.62 kilograms	Standard Deviation 19.58
Glargine	Actual Body Weight at Baseline and Endpoint (LOCF)	Endpoint	103.28 kilograms	Standard Deviation 19.42

p-value: 0.343ANCOVA

Secondary

Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)

Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.

Time frame: 24 weeks, Endpoint (LOCF) up to 24 weeks

Population: All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
ILPS	Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)	24 weeks	6.94 percent of glycosylated hemoglobin	Standard Error 0.07
ILPS	Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)	Endpoint (LOCF)	7.00 percent of glycosylated hemoglobin	Standard Error 0.07
Glargine	Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)	24 weeks	6.70 percent of glycosylated hemoglobin	Standard Error 0.06
Glargine	Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)	Endpoint (LOCF)	6.78 percent of glycosylated hemoglobin	Standard Error 0.07

p-value: 0.00395% CI: [0.08, 0.39]ANCOVA

p-value: 0.00895% CI: [0.06, 0.38]ANCOVA

Secondary

Change From Baseline in Body Weight at Endpoint (LOCF)

Time frame: Baseline, Endpoint (LOCF) up to 24 weeks

Population: All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Arm	Measure	Value (MEAN)	Dispersion
ILPS	Change From Baseline in Body Weight at Endpoint (LOCF)	0.27 kilograms	Standard Deviation 3.38
Glargine	Change From Baseline in Body Weight at Endpoint (LOCF)	0.66 kilograms	Standard Deviation 3.93

p-value: 0.041t-test, 2 sided

p-value: 0.34395% CI: [-1.15, 0.4]ANOVA

p-value: 0.417t-test, 2 sided

Secondary

Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)

Least squares mean values were controlled for Baseline + Baseline HbA1c Group + Baseline SU Group.

Time frame: Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks

Population: All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
ILPS	Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)	Baseline	8.48 percent of glycosylated hemoglobin	Standard Error 0.04
ILPS	Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)	24 Weeks Change	-1.25 percent of glycosylated hemoglobin	Standard Error 0.07
ILPS	Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)	Endpoint (LOCF) Change	-1.21 percent of glycosylated hemoglobin	Standard Error 0.07
Glargine	Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)	Baseline	8.47 percent of glycosylated hemoglobin	Standard Error 0.04
Glargine	Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)	24 Weeks Change	-1.49 percent of glycosylated hemoglobin	Standard Error 0.06
Glargine	Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)	Endpoint (LOCF) Change	-1.43 percent of glycosylated hemoglobin	Standard Error 0.07

p-value: 0.00395% CI: [0.08, 0.39]ANCOVA

p-value: 0.00895% CI: [0.06, 0.38]ANCOVA

Secondary

Glycemic Variability at Baseline and Endpoint (LOCF)

Glycemic variability was defined as the standard deviation (SD) of a participant's intra-day 7-point, self-monitored, blood glucose. Mean SD was calculated based on the SD for each participant in the study.

Time frame: Baseline, Endpoint (LOCF) up to 24 weeks

Population: All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Arm	Measure	Group	Value (MEAN)	Dispersion
ILPS	Glycemic Variability at Baseline and Endpoint (LOCF)	Baseline	41.15 mg/dL	Standard Deviation 13.69
ILPS	Glycemic Variability at Baseline and Endpoint (LOCF)	Endpoint	36.78 mg/dL	Standard Deviation 16.02
Glargine	Glycemic Variability at Baseline and Endpoint (LOCF)	Baseline	39.02 mg/dL	Standard Deviation 13.52
Glargine	Glycemic Variability at Baseline and Endpoint (LOCF)	Endpoint	30.96 mg/dL	Standard Deviation 13.24

p-value: 0.13195% CI: [-0.68, 5.22]ANOVA

p-value: <0.00195% CI: [2.82, 9.16]ANOVA

Secondary

Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)

Overall:any time after randomization.Episode:any time patient experienced sign/symptom associated with hypoglycemia, or had blood glucose level ≤70 mg/dL. Non-nocturnal:any episode that occurred between waking and bedtime. Nocturnal:any episode that occurred between bedtime and waking.Severe:episode with symptoms consistent with neuroglycopenia in which patient requires assistance,and is associated with:blood glucose value \<50 mg/dL or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.Incidence(%)=(Number of patients experiencing episodes/number of patients in arm)\*100.

Time frame: Baseline to Endpoint (LOCF) up to 24 weeks

Population: All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Arm	Measure	Group	Value (NUMBER)
ILPS	Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)	Nocturnal - Overall	47.6 percentage of participants
ILPS	Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)	All Reported - Overall	70.6 percentage of participants
ILPS	Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)	Non-Nocturnal - Endpoint	30.6 percentage of participants
ILPS	Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)	Non-Nocturnal - Overall	62.4 percentage of participants
ILPS	Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)	Nocturnal - Endpoint	21.8 percentage of participants
ILPS	Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)	Severe - Endpoint	0 percentage of participants
ILPS	Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)	Severe - Overall	1.8 percentage of participants
ILPS	Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)	All Reported - Endpoint	41.8 percentage of participants
Glargine	Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)	Severe - Endpoint	0 percentage of participants
Glargine	Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)	All Reported - Endpoint	43.1 percentage of participants
Glargine	Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)	Nocturnal - Endpoint	11.4 percentage of participants
Glargine	Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)	All Reported - Overall	74.9 percentage of participants
Glargine	Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)	Nocturnal - Overall	37.1 percentage of participants
Glargine	Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)	Non-Nocturnal - Endpoint	40.1 percentage of participants
Glargine	Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)	Severe - Overall	0 percentage of participants
Glargine	Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)	Non-Nocturnal - Overall	70.7 percentage of participants

p-value: 0.826Fisher Exact

p-value: 0.394Fisher Exact

p-value: 0.07Fisher Exact

p-value: 0.133Fisher Exact

p-value: 0.013Fisher Exact

p-value: 0.061Fisher Exact

p-value: 0.248Fisher Exact

Secondary

Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%

Time frame: Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks

Population: All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Arm	Measure	Group	Value (NUMBER)
ILPS	Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%	Week 18: HbA1c <7.0%	54.8 percent of participants
ILPS	Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%	Week 24: HbA1c <=6.5%	29.7 percent of participants
ILPS	Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%	Week 18: HbA1c <=6.5%	30.8 percent of participants
ILPS	Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%	Endpoint (LOCF): HbA1c <7.0%	53.7 percent of participants
ILPS	Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%	Week 12: HbA1c <=6.5%	24.8 percent of participants
ILPS	Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%	Endpoint (LOCF): HbA1c <=6.5%	28.4 percent of participants
ILPS	Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%	Week 24: HbA1c <7.0%	55.4 percent of participants
ILPS	Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%	Week 12: HbA1c <7.0%	46.9 percent of participants
Glargine	Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%	Week 18: HbA1c <7.0%	69.1 percent of participants
Glargine	Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%	Week 12: HbA1c <7.0%	50.7 percent of participants
Glargine	Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%	Week 12: HbA1c <=6.5%	28.7 percent of participants
Glargine	Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%	Week 18: HbA1c <=6.5%	37.6 percent of participants
Glargine	Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%	Week 24: HbA1c <7.0%	63.4 percent of participants
Glargine	Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%	Week 24: HbA1c <=6.5%	39.9 percent of participants
Glargine	Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%	Endpoint (LOCF): HbA1c <7.0%	61.7 percent of participants
Glargine	Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%	Endpoint (LOCF): HbA1c <=6.5%	38.9 percent of participants

p-value: 0.561Fisher Exact

p-value: 0.511Fisher Exact

p-value: 0.012Fisher Exact

p-value: 0.269Fisher Exact

p-value: 0.161Fisher Exact

p-value: 0.071Fisher Exact

p-value: 0.177Fisher Exact

p-value: 0.06Fisher Exact

Secondary

Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)

Rate of self-reported hypoglycemic episodes, all, non-nocturnal, and nocturnal, at Endpoint (LOCF) and overall. Rate is reported as episodes/participant/365 days. Episode = any time participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia or has a blood glucose level of ≤70 mg/dL, even if it was not associated with signs, symptoms, or treatment. Overall=any time during the post-randomization visits within the study period. Nocturnal=Any episode that occurs between bedtime and waking. Non-Nocturnal=Any episode that occurs between waking and bedtime.

Time frame: Baseline to Endpoint (LOCF) up to 24 weeks

Population: All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Arm	Measure	Group	Value (MEAN)	Dispersion
ILPS	Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)	All reported episodes rate - Endpoint	14.51 episodes/participant/365 days	Standard Deviation 27.75
ILPS	Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)	All reported episodes rate - Overall	16.27 episodes/participant/365 days	Standard Deviation 23.19
ILPS	Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)	Non-Nocturnal reported episodes rate - Endpoint	10.40 episodes/participant/365 days	Standard Deviation 23.46
ILPS	Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)	Non-Nocturnal reported episodes rate - Overall	11.36 episodes/participant/365 days	Standard Deviation 19.16
ILPS	Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)	Nocturnal reported episodes rate - Endpoint	4.01 episodes/participant/365 days	Standard Deviation 9.73
ILPS	Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)	Nocturnal reported episodes rate - Overall	4.88 episodes/participant/365 days	Standard Deviation 8.43
Glargine	Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)	Nocturnal reported episodes rate - Endpoint	1.73 episodes/participant/365 days	Standard Deviation 5.53
Glargine	Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)	All reported episodes rate - Endpoint	15.29 episodes/participant/365 days	Standard Deviation 29.73
Glargine	Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)	Non-Nocturnal reported episodes rate - Overall	14.83 episodes/participant/365 days	Standard Deviation 21
Glargine	Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)	All reported episodes rate - Overall	18.05 episodes/participant/365 days	Standard Deviation 24.59
Glargine	Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)	Nocturnal reported episodes rate - Overall	3.01 episodes/participant/365 days	Standard Deviation 7.21
Glargine	Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)	Non-Nocturnal reported episodes rate - Endpoint	13.20 episodes/participant/365 days	Standard Deviation 28.01

p-value: 0.628Negative Binomial regression model

p-value: 0.57Negative Binomial regression model

p-value: 0.116Negative Binomial regression model

p-value: 0.044Negative Binomial regression model

p-value: 0.006Negative Binomial regression model

p-value: 0.004Negative Binomial regression model

Secondary

Total Daily Insulin Dose at Endpoint (LOCF)

Time frame: Endpoint (LOCF) up to 24 weeks

Population: All randomized participants with at least one post-baseline measurement. Intention to Treat (ITT) population.

Arm	Measure	Value (MEAN)	Dispersion
ILPS	Total Daily Insulin Dose at Endpoint (LOCF)	31.11 Units of Insulin	Standard Deviation 18.87
Glargine	Total Daily Insulin Dose at Endpoint (LOCF)	37.93 Units of Insulin	Standard Deviation 18.46

p-value: <0.001ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide

Conditions

Brief summary

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

Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])

7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)

Actual Body Weight at Baseline and Endpoint (LOCF)

Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)

Change From Baseline in Body Weight at Endpoint (LOCF)

Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)

Glycemic Variability at Baseline and Endpoint (LOCF)

Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)

Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%

Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)

Total Daily Insulin Dose at Endpoint (LOCF)