Adjunctive Therapy of Exenatide or Sitagliptin to Insulin Glargine in Type 2 Diabetes
Information source: Profil Institut für 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 für 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
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