CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 222 enrolled
Drug / intervention
insulin detemir +3 moredrug
Likely dose
sitagliptin 100 mgfrom 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/NCT00789191
NCT00789191Phase 3Completed
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Effect of Detemir and Sitagliptin on Blood Glucose Control in Subjects With Type 2 Diabetes Mellitus

Novo Nordisk A/S·interventional·Posted Nov 11, 2008·Updated Mar 14, 2017

In Brief

A Phase 3 clinical trial evaluating insulin detemir, sitagliptin, and 2 other interventions for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 222 participants across 51 sites in 8 countries.

Detailed Summary

This trial is conducted in Asia, Europe and North America. This trial aims for comparison of the effect on the glycemic control in subjects with type 2 diabetes of basal insulin analogue with one oral anti-diabetic drug (OAD) versus oral anti-diabetic drug alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesCanada, Finland, France, Hungary, Slovakia, South Korea, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 11, 2008
Enrollment StartNov 1, 2008
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.6 years ago

Interventions

insulin detemirdrug

The detemir insulin dose is injected subcutaneously (under the skin) once daily in the evening and will be titrated (individually adjusted) weekly throughout the trial.

sitagliptindrug

The sitagliptin dose is 100 mg/ day and should be kept stable throughout the trial. Frequency of sitagliptin is once daily.

metformindrug

Metformin treatment with at least 1000 mg/ day. Dose and dosing frequency should remain unchanged throughout the trial.

sulphonylureadrug

Sulphonylurea (SU) dose and dosing frequency should initially remain unchanged. In case of hypoglycaemia SU dose may be reduced at the discretion of the investigator.