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
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
Clinical Details
Official title: Superiority Study of Insulin Glargine Over Sitagliptin in Insulin-naïve 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 EndpointHbA1c 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
Eligibility
Minimum age: 35 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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.
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
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