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Adjunctive Therapy of Exenatide or Sitagliptin to Insulin Glargine in Type 2 Diabetes

NCT00971659 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2009-09-04

No results posted yet for this study

Summary

This study investigated a 4-week adjunctive therapy of either a GLP-1 analog (exenatide), or a DPP-4 inhibitor (sitagliptin), given to a basal insulin analog (insulin glargine), and their effect on blood glucose control, versus insulin glargine alone as active comparator in type 2 diabetes.

Conditions

Interventions

DRUG

insulin glargine + exenatide + preexisting metformin

insulin glargine once daily subcutaneously over 4 weeks, dose adjustment according to a treat-to-target algorithm, exenatide 5ug twice daily subcutaneously for 2 weeks, then 10ug twice daily for 2 weeks, continuation of preexisting metformin

DRUG

insulin glargine + sitagliptin + preexisting metformin

insulin glargine once daily subcutaneously over 4 weeks, dose adjustment according to a treat-to-target algorithm, sitagliptin 100 mg once daily in the morning over 4 weeks, continuation of preexisting metformin

DRUG

insulin glargine + preexisting metformin

insulin glargine once daily subcutaneously over 4 weeks, continuation of preexisting metformin

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Profil Institut für Stoffwechselforschung GmbH

    lead INDUSTRY

Principal Investigators

  • Sabine Arnolds, MD · Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

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
2008-01-31
Primary Completion
2008-09-30
Completion
2008-11-30

Countries

  • Germany

Study Locations

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Entities

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 NCT00971659 on ClinicalTrials.gov