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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
Profil Institut für Stoffwechselforschung GmbH
ClinicalTrials.gov Identifier:
NCT00971659
First received: September 3, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
 Drug: insulin glargine + exenatide + preexisting metformin
Drug: insulin glargine + sitagliptin + preexisting metformin
Drug: insulin glargine + preexisting metformin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acute Effect of a GLP-1-Analogue (Exenatide) and of a DPP-4-Inhibitor (Sitagliptin) in Subjects With Type 2 Diabetes Treated With Insulin Glargine Once Daily

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Profil Institut für Stoffwechselforschung GmbH:

Primary Outcome Measures:
  • the unadjusted 6-hour postprandial blood glucose excursion (AUCBG0-6h) following ingestion of a standardized breakfast [ Time Frame: after 4 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mean daily blood glucose (BG) from 7-point 24h BG profiles, fasting BG, self-measured 7-point BG profiles, percentage of subjects achieving ADA HbA1c treatment goals, fasting lipid profiles, HOMA-IR index, hypoglycemic episodes [ Time Frame: after 4 weeks of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: January 2008
Study Completion Date: November 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: insulin glargine + exenatide + metformin 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
Other Names:
  • Lantus
  • Byetta
Experimental: Insulin glargine + sitagliptin + 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
Other Names:
  • Lantus
  • Januvia
Active Comparator: insulin glargine + metformin Drug: insulin glargine + preexisting metformin
insulin glargine once daily subcutaneously over 4 weeks, continuation of preexisting metformin
Other Name: Lantus

Detailed Description:

Due to the different mechanisms of action of the long-acting insulin analog insulin glargine and both a GLP-1 analog (exenatide) and a DPP-4-inhibitor (sitagliptin), it could be a promising approach to combine insulin glargine with either exenatide or sitagliptin for optimum control of fasting and postprandial blood glucose values. Thus, in the present study the influence of either exenatide or sitagliptin as a 4-week adjunctive therapy to a basal insulin (insulin glargine) was investigated versus insulin glargine alone as active comparator in subjects with type 2 diabetes. Preexisting metformin was continued, sulfonylureas, if any, were stopped. In particular, the effects on postprandial blood glucose excursion following ingestion of a standard breakfast, assessed after 4 weeks of treatment, the effects on mean daily blood glucose, on self-measured 7-point profiles, the percentage of subjects reaching ADA treatment goals (HbA1c < 7.0%) at the end of treatment, on fasting lipid profile, on HOMA index, weight, hypoglycemic episodes and general safety were assessed. The study consisted of a screening visit, a 4-8 week (depending on pre-treatment) run-in period, a 4-week treatment period, and a follow-up visit. There were weekly visits at the site and twice weekly telephone contacts.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male or female subjects aged between 35 and 70 years, inclusive
  • type 2 diabetes with duration >6 months and <10 years
  • for at least 3 months: treatment solely with a long- or intermediate-acting insulin formulation (insulin glargine, insulin detemir, or NPH insulin) with or without a stable dose of metformin or treatment solely with a stable dose of metformin or combination of stable doses of metformin plus sulfonylureas
  • HbA1c >=7.0% and <=10.0%
  • if treated with antihypertensive or lipid lowering agents, the treatment regimen had to be stable during 3 months prior to study start
  • written informed consent

Exclusion Criteria:

  • history or presence of cancer or any clinically relevant diseases
  • chronic heart failure NYHA class III or IV, unstable angina pectoris or myocardial infarction within the previous 6 months
  • recurrent hypoglycemia
  • abnormal lab tests at screening (ALAT and/or ASAT >=3 times ULN), creatinine >1.6 mg/dL in males and >1.4 mg/dL in females
  • clinically relevant ECG findings at screening
  • treatment with a rapid-acting insulin or with a mixed insulin formulation during the previous 3 months
  • treatment with any other OHA than metformin or metformin plus sulfonylureas during the previous 3 months
  • any systemic or topical treatment with drugs known to influence glucose metabolism
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00971659

Locations
Germany
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, 41460
Sponsors and Collaborators
Profil Institut für Stoffwechselforschung GmbH
Sanofi
Investigators
Principal Investigator: Sabine Arnolds, MD Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany
  More Information

No publications provided by Profil Institut für Stoffwechselforschung GmbH

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Christoph Kapitza, MD, Profil Institut für Stoffwechselforschung GmbH
ClinicalTrials.gov Identifier: NCT00971659     History of Changes
Other Study ID Numbers: 49/0316-Adjunct
Study First Received: September 3, 2009
Last Updated: September 3, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Profil Institut für Stoffwechselforschung GmbH:
type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Glargine
Sitagliptin
Insulin
 Metformin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013