CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 515 enrolled
Drug / intervention
Insulin Glargine +2 moredrug
Likely dose
Insulin Glargine 100 Unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00751114
NCT00751114Phase 4Completed
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Superiority Study of Insulin Glargine Over Sitagliptin in Insulin-naïve Patients With Type 2 Diabetes Treated With Metformin and Not Adequately Controlled

Sanofi·interventional·Posted Sep 11, 2008·Updated Sep 10, 2012

In Brief

A Phase 4 clinical trial evaluating Insulin Glargine, Sitagliptin, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 515 participants across 17 sites in 17 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesAustria, Brazil, Colombia, Egypt, Greece, Hong Kong, India, Israel, Lebanon, Mexico, Netherlands, Portugal, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 11, 2008
Enrollment StartNov 1, 2008
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 17.8 years ago

Interventions

Insulin Glarginedrug

Subcutaneous injection. 100 Units/mL solution for injection in a pre-filled SoloStar® pen (3 mL).

Sitagliptindrug

Oral administration. 100 mg film-coated tablets.

Metformindrug

Patients continued with metformin as usual oral anti-diabetic treatment.