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NCT00851903 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Sanofi.

Completed
Registry status
Phase 3
Development phase
112
Enrollment target

NCT00851903: Completed Phase 3 study, sponsored by Sanofi.

NCT00851903 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 112 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00851903, a Phase 3 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 3
Development phase
112 participants
Enrollment target

Study 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.

Interventions

  • DRUG Metformin
  • DRUG Sitagliptin
  • DRUG Insulin Glargine

Trial Details

FieldValue
Enrollment Target 112 participants
Start Date 2009-06
Est. Completion 2011-09
Phase Phase 3
Sanofi

713 total trials

What the finished NCT00851903 record still lists

NCT00851903 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).

The record links to 0 conditions, and to 3 interventions - of which Metformin is the first listed.

NCT00851903 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00851903 about?

NCT00851903 is a clinical study titled "Evaluation of Insulin Glargine in Combination With Sitagliptin in Type 2 Diabetes Patients: EASIE Extension Trial". 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% a...

What is the current status of trial NCT00851903?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 112 participants. The study started on 2009-06. Estimated completion is 2011-09.

What interventions are being tested in trial NCT00851903?

The interventions under investigation include: Metformin (DRUG), Sitagliptin (DRUG), Insulin Glargine (DRUG).

Who is sponsoring clinical trial NCT00851903?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00851903's enrollment target sits among peer trials

112 1652nd of 2000 higher than 346 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00851903, the US trial registry maintained by the National Library of Medicine. NCT00851903 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.