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Evaluation of Insulin Glargine in Combination With Sitagliptin in Type 2 Diabetes Patients: EASIE Extension Trial

NCT00851903 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2012-10-04

Study results available
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Summary

This study was the extension of the LANTU\_C\_02761 study named EASIE and identified as NCT00751114 (core study comparing insulin glargine versus sitagliptin in insulin-naïve patients treated with metformin and not adequately controlled).

All patients with Glycosylated Hemoglobin A1c (HbA1c) ≥ 7% at the end of the core study had the possibility to enter this extension study if they met the other inclusion criteria and did not present with any exclusion criteria.

The visit 14 of the core study (week 24) was the visit 1 (baseline, week 0) of the extension study which consisted of a 12-week treatment period.

The objectives of this extension study were:

* To assess the glycemic control (HbA1c \<7%) of a 3-month combination therapy with metformin, insulin glargine and sitagliptin in patients not adequately controlled by a previous treatment with metformin plus either insulin glargine or sitagliptin.
* To assess the effect of insulin glargine in combination with sitagliptin on HbA1c level, fasting plasma glucose, 7-point glucose profile, hypoglycemia occurrence, body weight and overall safety.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Insulin Glargine

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

DRUG

Sitagliptin

Oral administration. 100mg 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
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

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

Study Locations

More Related Trials

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 NCT00851903 on ClinicalTrials.gov