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

Information source: Profil Institut fr Stoffwechselforschung GmbH
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes

Intervention: insulin glargine + exenatide + preexisting metformin (Drug); insulin glargine + sitagliptin + preexisting metformin (Drug); insulin glargine + preexisting metformin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Profil Institut fr Stoffwechselforschung GmbH

Official(s) and/or principal investigator(s):
Sabine Arnolds, MD, Principal Investigator, Affiliation: Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: the unadjusted 6-hour postprandial blood glucose excursion (AUCBG0-6h) following ingestion of a standardized breakfast

Secondary outcome: 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

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

Minimum age: 35 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Profil Institut für Stoffwechselforschung GmbH, Neuss 41460, Germany
Additional Information

Starting date: January 2008
Last updated: September 3, 2009

Page last updated: August 23, 2015

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