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Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-naive Patients

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: Insulin Glargine (Drug); Sitagliptin (Drug); Metformin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Clinical Sciences & Operations, Study Director, Affiliation: Sanofi


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

Clinical Details

Official title: Superiority Study of Insulin Glargine Over Sitagliptin in Insulin-nave Patients With Type 2 Diabetes Treated With Metformin and Not Adequately Controlled

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: HbA1c: Change From Baseline to Study Endpoint

Secondary outcome:

HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 7% at Study Endpoint

HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 6.5% at Study Endpoint

Self-monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint

7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint

Insulin Dose in the Insulin Glargine Group

Lipid Profile: Change From Baseline to Study Endpoint

Change in Body Weight From Baseline to Study Endpoint

Number of Patients With at Least One Episode of Symptomatic Hypoglycemia

Number of Patients With at Least One Episode of Severe Symptomatic Hypoglycemia


Minimum age: 35 Years. Maximum age: 70 Years. Gender(s): Both.


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


- 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


- 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.

Locations and Contacts

Sanofi-Aventis Administrative Office, Vienna, Austria

Sanofi-Aventis Administrative Office, Sao Paulo, Brazil

Sanofi-Aventis Administrative Office, Bogota, Colombia

Sanofi-Aventis Administrative Office, Cairo, Egypt

Sanofi-Aventis Administrative Office, Kallithea, Greece

Sanofi-Aventis Administrative Office, Hong Kong, Hong Kong

Sanofi-Aventis Administrative Office, Mumbai, India

Sanofi-Aventis Administrative Office, Natanya, Israel

Sanofi-Aventis Administrative Office, Seoul, Korea, Republic of

Sanofi-Aventis Administrative Office, Beirut, Lebanon

Sanofi-Aventis Administrative Office, Col. Coyoacan, Mexico

Sanofi-Aventis Administrative Office, Gouda, Netherlands

Sanofi-Aventis Administrative Office, Porto Salvo, Portugal

Sanofi-Aventis Administrative Office, Barcelona, Spain

Sanofi-Aventis Administrative Office, Istanbul, Turkey

Sanofi-Aventis Administrative Office, Guildford Surrey, United Kingdom

Sanofi-Aventis Administrative Office, Bridgewater, New Jersey 08807, United States

Additional Information

Starting date: November 2008
Last updated: September 3, 2012

Page last updated: August 23, 2015

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