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Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-naive Patients

NCT00751114 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 515

Last updated 2012-09-10

Study results available
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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

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Insulin Glargine

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

DRUG

Sitagliptin

Oral administration. 100 mg film-coated tablets.

DRUG

Metformin

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States
  • Austria
  • Brazil
  • Colombia
  • Egypt
  • Greece
  • Hong Kong
  • India
  • Israel
  • Lebanon
  • Mexico
  • Netherlands
  • Portugal
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00751114 on ClinicalTrials.gov