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Effect of Detemir and Sitagliptin on Blood Glucose Control in Type 2 Diabetes

NCT00789191 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2017-03-14

Study results available
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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.

Conditions

Interventions

DRUG

insulin detemir

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.

DRUG

sitagliptin

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

DRUG

metformin

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

DRUG

sulphonylurea

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.

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • United States
  • Canada
  • Finland
  • France
  • Hungary
  • Slovakia
  • South Korea
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT00789191 on ClinicalTrials.gov