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Trial · Interventional

CompletedPhase 1Registry data

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

Overview

Status
Completed
Phase
Phase 1
Enrollment
48 participants (actual)
Sponsor
Profil Institut für Stoffwechselforschung GmbH · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Germany

Start
Jan 2008
Primary completion
Sept 2008
Completion
Nov 2008
First posted
4 Sept 2009 (estimated)
Last update posted
4 Sept 2009 (estimated)
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20082009
  1. Ph 1

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

    NCT00971659

    Jan 2008 to Nov 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • insulin glargine + exenatide + preexisting metforminDrug
  • insulin glargine + sitagliptin + preexisting metforminDrug
  • insulin glargine + preexisting metforminDrug

Arms3

  • Experimental

    insulin glargine + exenatide + metformin

  • Experimental

    Insulin glargine + sitagliptin + metformin

  • Active comparator

    insulin glargine + metformin

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. the unadjusted 6-hour postprandial blood glucose excursion (AUCBG0-6h) following ingestion of a standardized breakfast

    Time frame · after 4 weeks of treatment

Secondary outcomes(1)
  1. 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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2010

12 results

Further improvement in postprandial glucose control with addition of exenatide or sitagliptin to combination therapy with insulin glargine and metformin: a proof-of-concept study.

Arnolds et al. 2010Diabetes carecited by 131

PMID 20357372PMC2890351DOI 10.2337/dc09-2191PUB-20357372

Free to read · publisher termsCC BY-NC-ND12 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 35 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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