Diabetes Mellitus, Type 2
Conditions
Brief summary
The primary objective was to demonstrate the superiority of insulin glargine over sitagliptin in reducing Glycosylated Hemoglobin A1c (HbA1c) from baseline to the end of the treatment period. Secondary objective was to assess the effect of insulin glargine in comparison with sitagliptin on: * HbA1c level * Fasting Plasma Glucose (FPG) * 7-point plasma glucose (PG) profiles * Percentage of patients with HbA1c \<7% and \<6.5% Safety objectives consisted of: * Hypoglycemia occurrence * Body weight * Overall safety
Interventions
DRUGInsulin Glargine
Subcutaneous injection. 100 Units/mL solution for injection in a pre-filled SoloStar® pen (3 mL).
DRUGSitagliptin
Oral administration. 100 mg film-coated tablets.
DRUGMetformin
Patients continued with metformin as usual oral anti-diabetic treatment.
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* With type 2 diabetes diagnosed for at least 6 months, * Not previously treated with insulin, * On metformin for at least 3 months and a stable minimal dose of 1 g/day for at least 2 months * HbA1c ≥ 7 and \< 11 %, * Body Mass Index (BMI) between 25 and 45 kg/m² inclusively, * Ability and willingness to perform plasma glucose (PG) monitoring using the Sponsor-provided PG meter and to complete the patient diary, * Signed informed consent obtained prior any study procedures, * Willingness and ability to comply with the study protocol.
Exclusion criteria
* Treatment with oral antidiabetic drugs other than metformin within the last 3 months, * Previous treatment with the combination of metformin + sulfonylurea for more than 1 year, * Previous treatment with Glucagon Like Peptide-1 (GLP-1) agonists or DiPeptidyl Peptidase (DPP) IV inhibitors, * FPG (assessed by central laboratory measurement) ≥ 280 mg/dL (15.4 mmol/L), * Diabetes other than type 2 diabetes (e.g. secondary to pancreatic disorders, drug or chemical agents intake...), * Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method), * In-patient care, * Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study (an optic fundus examination should have been performed within the 2 years prior to study entry), * Impaired renal function: serum creatinine ≥ 1.5 mg/dL (≥ 133µmol/L) or ≥ 1.4 mg/dL (≥ 124 µmol/L) in men and women, respectively, * History of sensitivity to the study drugs or to drugs with a similar chemical structure, * Impaired hepatic function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) \> 3 x upper limit of normal range, * Treatment with systemic corticosteroids within the 3 months prior to study entry or likelihood of requiring treatment during the study that are not permitted during the study (exception: in case of chronic adrenal insufficiency, systemic glucosteroids are accepted only if the disease is stable and the treatment dose stable for at least 3 months before study entry), * Alcohol or drug abuse within the last year, * Night shift worker, * Presence of any condition (medical, psychological, social or geographical), current or anticipated that the investigator feels would compromise the patient's safety or limit the patient successful participation in the study, * Treatment with weight loss medications (e.g. sibutramine, orlistat, rimonabant) within the last 3 months, * Participation in another clinical trial within the month prior to visit 1, * History of pancreatitis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c: Change From Baseline to Study Endpoint | baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14 | Change in HbA1c from baseline to study endpoint defined as the last available HbA1c value measured during the 24-week treatment period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 6.5% at Study Endpoint | study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14 | — |
| Self-monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint | baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available value | SMFPG mean = mean of the fasting plasma glucose values recorded on the 6 consecutive days before the visit (at least 3 values needed). Study endpoint was defined as the last available SMFPG mean value collected on-treatment. Change= study endpoint - baseline |
| 7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint | baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14 | 7-point plasma glucose recorded before and after breakfast, before and after lunch, before and after dinner and at bedtime. Change = study endpoint - baseline. |
| Insulin Dose in the Insulin Glargine Group | visit 4 (week 2), visit 8 (week 6), visit 11 (week 12), visit 12 (week 16), visit 14 (week 24), first dose received defined as first available value, study endpoint defined as last available value | Daily dose at the face-to-face visits. |
| HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 7% at Study Endpoint | study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14 | — |
| Change in Body Weight From Baseline to Study Endpoint | baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available value | — |
| Number of Patients With at Least One Episode of Symptomatic Hypoglycemia | During the treatment phase (24 weeks) plus 7 days after last dose | Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia confirmed or not by a plasma glucose measurement \<= 70mg/dL \[3.9 mmol/L\] |
| Number of Patients With at Least One Episode of Severe Symptomatic Hypoglycemia | During the treatment phase (24 weeks) plus 7 days after last dose | Severe symptomatic hypoglycemia was defined as an event with clinical symptoms which required assistance of another person and with either a Plasma Glucose level \< 36 mg/dL (2 mmol/L) or with a prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration |
| Lipid Profile: Change From Baseline to Study Endpoint | baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14 | — |
Countries
Austria, Brazil, Colombia, Egypt, Greece, Hong Kong, India, Israel, Lebanon, Mexico, Netherlands, Portugal, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States
Participant flow
Recruitment details
EASIE was a multicenter, international, randomized, open-label trial conducted from November 12, 2008 to July 28, 2011.
Pre-assignment details
A total of 732 patients were screened in 96 centers in 17 countries. The study included an initial 2-week screening period. A total of 217 patients were screen failures. The main reason for screen failure was Glycosylated Hemoglobin A1c (HbA1c) inclusion criterion not met (146 patients).
Participants by arm
| Arm | Count |
|---|---|
| Insulin Glargine Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL\<FPG≤100mg/dL (3.9mmol/L\<FPG≤5.5mmol/L) | 227 |
| Sitagliptin Dose of 100 mg once a day administered with or without food | 253 |
| Total | 480 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 4 |
| Overall Study | Lack of Efficacy | 0 | 7 |
| Overall Study | Lost to Follow-up | 4 | 7 |
| Overall Study | Move to another city | 1 | 0 |
| Overall Study | Not Treated | 13 | 1 |
| Overall Study | Out of country for 2 months | 1 | 0 |
| Overall Study | Protocol Violation | 8 | 9 |
| Overall Study | Withdrawal by Subject | 9 | 4 |
Baseline characteristics
| Characteristic | Total | Insulin Glargine | Sitagliptin |
|---|---|---|---|
| Age Continuous | 53.6 years STANDARD_DEVIATION 8.8 | 53.9 years STANDARD_DEVIATION 8.9 | 53.3 years STANDARD_DEVIATION 8.7 |
| At least one diabetic late complication No | 348 participants | 162 participants | 186 participants |
| At least one diabetic late complication Yes | 132 participants | 65 participants | 67 participants |
| Body Mass Index | 31.09 kg/m² STANDARD_DEVIATION 4.93 | 31.05 kg/m² STANDARD_DEVIATION 4.93 | 31.13 kg/m² STANDARD_DEVIATION 4.95 |
| Body Weight | 83.8 kg STANDARD_DEVIATION 18.2 | 83.4 kg STANDARD_DEVIATION 18.2 | 84.2 kg STANDARD_DEVIATION 18.3 |
| Diastolic Blood Pressure | 79.7 mmHg STANDARD_DEVIATION 8.5 | 79.5 mmHg STANDARD_DEVIATION 8.7 | 80.0 mmHg STANDARD_DEVIATION 8.3 |
| Duration of diabetes | 4.5 years | 3.9 years | 4.8 years |
| Fasting Plasma Glucose | 167.5 mg/dL STANDARD_DEVIATION 41.9 | 163.6 mg/dL STANDARD_DEVIATION 42 | 171.1 mg/dL STANDARD_DEVIATION 41.5 |
| Glycosylated Hemoglobin A1c (HbA1c) | 8.5 percent STANDARD_DEVIATION 1.1 | 8.5 percent STANDARD_DEVIATION 1 | 8.5 percent STANDARD_DEVIATION 1.1 |
| Heart Rate | 76.0 beats/min STANDARD_DEVIATION 9 | 75.6 beats/min STANDARD_DEVIATION 8.7 | 76.3 beats/min STANDARD_DEVIATION 9.3 |
| High-Density Lipoprotein (HDL) Cholesterol | 45.6 mg/dL STANDARD_DEVIATION 12.9 | 46.2 mg/dL STANDARD_DEVIATION 14.6 | 45.0 mg/dL STANDARD_DEVIATION 11.2 |
| Low-Density Lipoprotein (LDL) Cholesterol | 113.5 mg/dL STANDARD_DEVIATION 34.6 | 112.7 mg/dL STANDARD_DEVIATION 36.2 | 114.2 mg/dL STANDARD_DEVIATION 33.2 |
| Self-monitored Fasting Plasma Glucose | 165.4 mg/dL STANDARD_DEVIATION 37.9 | 163.9 mg/dL STANDARD_DEVIATION 37.6 | 166.7 mg/dL STANDARD_DEVIATION 38.2 |
| Sex/Gender, Customized Female | 234 participants | 113 participants | 121 participants |
| Sex/Gender, Customized Male | 246 participants | 114 participants | 132 participants |
| Systolic Blood Pressure | 130.8 mmHg STANDARD_DEVIATION 14.3 | 129.8 mmHg STANDARD_DEVIATION 13.3 | 131.7 mmHg STANDARD_DEVIATION 15.1 |
| Total Cholesterol | 186.5 mg/dL STANDARD_DEVIATION 40.1 | 185.9 mg/dL STANDARD_DEVIATION 41.4 | 187.1 mg/dL STANDARD_DEVIATION 39 |
| Triglycerides | 188.2 mg/dL STANDARD_DEVIATION 128.3 | 190.9 mg/dL STANDARD_DEVIATION 142 | 185.7 mg/dL STANDARD_DEVIATION 114.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 27 / 237 | 41 / 264 |
| serious Total, serious adverse events | 15 / 237 | 8 / 264 |
Outcome results
Primary
HbA1c: Change From Baseline to Study Endpoint
Change in HbA1c from baseline to study endpoint defined as the last available HbA1c value measured during the 24-week treatment period.
Time frame: baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14
Population: The population analyzed for this outcome measure consisted of the subset of mITT patients who had both baseline and endpoint measurements.~The Last Observation Carried Forward method was used for imputing missing data for the end of treatment value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Glargine | HbA1c: Change From Baseline to Study Endpoint | -1.72 percent | Standard Error 0.06 |
| Sitagliptin | HbA1c: Change From Baseline to Study Endpoint | -1.13 percent | Standard Error 0.06 |
Comparison: H0: no difference between insulin glargine mean HbA1c change and sitagliptin mean HbA1c change~H1: difference between insulin glargine mean HbA1c change and sitagliptin mean HbA1c change~Assuming:~* Estimated standard deviation of the change in HbA1c of 1.3%~* Expected mean difference to be detected of 0.4%~* Alpha risk of 5% (two-sided)~* Power of 90%~* Equal sample size in each treatment group (1:1 randomization)~A total number of 446 evaluable patients (223 in each group) was requiredp-value: <0.000195% CI: [-0.77, -0.42]ANCOVA
Secondary
7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint
7-point plasma glucose recorded before and after breakfast, before and after lunch, before and after dinner and at bedtime. Change = study endpoint - baseline.
Time frame: baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14
Population: The population analyzed for this outcome measure consisted of the subset of mITT patients who had valid 7-point plasma glucose profiles (4 points needed for a valid profile) both at baseline and endpoint.~Depending on the time point, few values were missing.~Adjusted means were estimated from ANCOVA model using baseline value as covariate.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Glargine | 7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint | Before lunch (N ig = 201 & N s = 223) | -48.00 mg/dL | Standard Error 2.33 |
| Insulin Glargine | 7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint | After dinner (N ig = 196 & N s = 220) | -45.88 mg/dL | Standard Error 2.69 |
| Insulin Glargine | 7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint | After breakfast (N ig = 202 & N s = 220) | -66.25 mg/dL | Standard Error 3.03 |
| Insulin Glargine | 7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint | At bedtime (N ig = 177 & N s = 210) | -45.58 mg/dL | Standard Error 3.15 |
| Insulin Glargine | 7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint | Before dinner (N ig = 199 & N s = 223) | -40.68 mg/dL | Standard Error 2.61 |
| Insulin Glargine | 7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint | After lunch (N ig = 202 & N s = 226) | -45.54 mg/dL | Standard Error 2.82 |
| Insulin Glargine | 7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint | Before breakfast (N ig = 203 & N s = 226) | -59.90 mg/dL | Standard Error 2.02 |
| Sitagliptin | 7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint | After lunch (N ig = 202 & N s = 226) | -26.10 mg/dL | Standard Error 2.66 |
| Sitagliptin | 7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint | Before breakfast (N ig = 203 & N s = 226) | -20.39 mg/dL | Standard Error 1.91 |
| Sitagliptin | 7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint | After breakfast (N ig = 202 & N s = 220) | -36.41 mg/dL | Standard Error 2.9 |
| Sitagliptin | 7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint | Before lunch (N ig = 201 & N s = 223) | -19.82 mg/dL | Standard Error 2.21 |
| Sitagliptin | 7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint | Before dinner (N ig = 199 & N s = 223) | -25.07 mg/dL | Standard Error 2.47 |
| Sitagliptin | 7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint | After dinner (N ig = 196 & N s = 220) | -33.78 mg/dL | Standard Error 2.54 |
| Sitagliptin | 7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint | At bedtime (N ig = 177 & N s = 210) | -31.16 mg/dL | Standard Error 2.89 |
Secondary
Change in Body Weight From Baseline to Study Endpoint
Time frame: baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available value
Population: The population analyzed for this outcome measure consisted of the subset of the safety population (treated patients) who had both baseline and endpoint measurements.~Adjusted means were estimated from ANCOVA model using baseline value as covariate.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Glargine | Change in Body Weight From Baseline to Study Endpoint | 0.44 kg | Standard Error 0.22 |
| Sitagliptin | Change in Body Weight From Baseline to Study Endpoint | -1.08 kg | Standard Error 0.2 |
Secondary
HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 6.5% at Study Endpoint
Time frame: study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14
Population: The population analyzed for this outcome measure consisted of the subset of mITT patients who had endpoint measurements.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Glargine | HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 6.5% at Study Endpoint | 40.2 percentage of participants |
| Sitagliptin | HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 6.5% at Study Endpoint | 16.9 percentage of participants |
Secondary
HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 7% at Study Endpoint
Time frame: study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14
Population: The population analyzed for this outcome measure consisted of the subset of mITT patients who had endpoint measurements.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Glargine | HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 7% at Study Endpoint | 67.9 percentage of participants |
| Sitagliptin | HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 7% at Study Endpoint | 41.9 percentage of participants |
Secondary
Insulin Dose in the Insulin Glargine Group
Daily dose at the face-to-face visits.
Time frame: visit 4 (week 2), visit 8 (week 6), visit 11 (week 12), visit 12 (week 16), visit 14 (week 24), first dose received defined as first available value, study endpoint defined as last available value
Population: The population analyzed for this outcome was the safety population defined as randomized patients who received at least one dose of investigational product.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Glargine | Insulin Dose in the Insulin Glargine Group | First dose received N=236 | 0.19 unit per kg body weight | Standard Deviation 0.03 |
| Insulin Glargine | Insulin Dose in the Insulin Glargine Group | Visit 14 (week 24) N=220 | 0.50 unit per kg body weight | Standard Deviation 0.26 |
| Insulin Glargine | Insulin Dose in the Insulin Glargine Group | Study endpoint N=237 | 0.49 unit per kg body weight | Standard Deviation 0.26 |
| Insulin Glargine | Insulin Dose in the Insulin Glargine Group | Visit 4 (week 2) N=230 | 0.27 unit per kg body weight | Standard Deviation 0.08 |
| Insulin Glargine | Insulin Dose in the Insulin Glargine Group | Visit 8 (week 6) N=222 | 0.38 unit per kg body weight | Standard Deviation 0.16 |
| Insulin Glargine | Insulin Dose in the Insulin Glargine Group | Visit 11 (week 12) N=219 | 0.45 unit per kg body weight | Standard Deviation 0.2 |
| Insulin Glargine | Insulin Dose in the Insulin Glargine Group | Visit 12 (week 16) N=214 | 0.48 unit per kg body weight | Standard Deviation 0.23 |
Secondary
Lipid Profile: Change From Baseline to Study Endpoint
Time frame: baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14
Population: The population analyzed for this outcome measure consisted of the subset of mITT patients who had both baseline and endpoint measurements.~Adjusted means were estimated from ANCOVA model using baseline value as covariate.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Glargine | Lipid Profile: Change From Baseline to Study Endpoint | Change in Total Cholesterol | -7.94 mg/dL | Standard Error 2.06 |
| Insulin Glargine | Lipid Profile: Change From Baseline to Study Endpoint | Change in LDL Cholesterol | -3.68 mg/dL | Standard Error 1.71 |
| Insulin Glargine | Lipid Profile: Change From Baseline to Study Endpoint | Change in HDL Cholesterol | 0.13 mg/dL | Standard Error 0.54 |
| Insulin Glargine | Lipid Profile: Change From Baseline to Study Endpoint | Change in Triglycerides | -34.07 mg/dL | Standard Error 8.14 |
| Sitagliptin | Lipid Profile: Change From Baseline to Study Endpoint | Change in Triglycerides | 0.31 mg/dL | Standard Error 7.78 |
| Sitagliptin | Lipid Profile: Change From Baseline to Study Endpoint | Change in Total Cholesterol | -1.54 mg/dL | Standard Error 1.97 |
| Sitagliptin | Lipid Profile: Change From Baseline to Study Endpoint | Change in HDL Cholesterol | 0.57 mg/dL | Standard Error 0.52 |
| Sitagliptin | Lipid Profile: Change From Baseline to Study Endpoint | Change in LDL Cholesterol | -0.19 mg/dL | Standard Error 1.63 |
Secondary
Number of Patients With at Least One Episode of Severe Symptomatic Hypoglycemia
Severe symptomatic hypoglycemia was defined as an event with clinical symptoms which required assistance of another person and with either a Plasma Glucose level \< 36 mg/dL (2 mmol/L) or with a prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration
Time frame: During the treatment phase (24 weeks) plus 7 days after last dose
Population: The population analyzed for this outcome measure was the safety population (treated patients)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Glargine | Number of Patients With at Least One Episode of Severe Symptomatic Hypoglycemia | 3 participants |
| Sitagliptin | Number of Patients With at Least One Episode of Severe Symptomatic Hypoglycemia | 1 participants |
Secondary
Number of Patients With at Least One Episode of Symptomatic Hypoglycemia
Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia confirmed or not by a plasma glucose measurement \<= 70mg/dL \[3.9 mmol/L\]
Time frame: During the treatment phase (24 weeks) plus 7 days after last dose
Population: The population analyzed for this outcome measure was the safety population (treated patients)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Glargine | Number of Patients With at Least One Episode of Symptomatic Hypoglycemia | 108 participants |
| Sitagliptin | Number of Patients With at Least One Episode of Symptomatic Hypoglycemia | 35 participants |
Secondary
Self-monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint
SMFPG mean = mean of the fasting plasma glucose values recorded on the 6 consecutive days before the visit (at least 3 values needed). Study endpoint was defined as the last available SMFPG mean value collected on-treatment. Change= study endpoint - baseline
Time frame: baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available value
Population: The population analyzed for this outcome measure consisted of the subset of mITT patients who had both baseline and endpoint measurements.~Adjusted means were estimated from ANCOVA model using baseline value as covariate.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Glargine | Self-monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint | -60.52 mg/dL | Standard Error 1.85 |
| Sitagliptin | Self-monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint | -19.35 mg/dL | Standard Error 1.73 |