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

NCT00971659 | Completed Phase 1

• 1 other identifier: 49/0316-Adjunct
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Type 2 Diabetes

Keywords

type 2 diabetes

Outcome Measures

Primary Outcomes (1)

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

  after 4 weeks of treatment

Secondary Outcomes (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

  after 4 weeks of treatment

Study Arms (3)

insulin glargine + exenatide + metformin

EXPERIMENTAL

Drug: insulin glargine + exenatide + preexisting metformin

Insulin glargine + sitagliptin + metformin

EXPERIMENTAL

Drug: insulin glargine + sitagliptin + preexisting metformin

insulin glargine + metformin

ACTIVE COMPARATOR

Drug: insulin glargine + preexisting metformin

Interventions

insulin glargine + exenatide + preexisting metformin DRUG

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

Also known as: Lantus, Byetta

insulin glargine + exenatide + metformin

insulin glargine + sitagliptin + preexisting metformin DRUG

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

Also known as: Lantus, Januvia

Insulin glargine + sitagliptin + metformin

insulin glargine + preexisting metformin DRUG

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

Also known as: Lantus

insulin glargine + metformin

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Profil Institut für Stoffwechselforschung GmbH: lead
• Sanofi: collaborator

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

Related Publications (1)

• Arnolds S, Dellweg S, Clair J, Dain MP, Nauck MA, Rave K, Kapitza C. 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. Diabetes Care. 2010 Jul;33(7):1509-15. doi: 10.2337/dc09-2191. Epub 2010 Mar 31.

  PMID: 20357372 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; Exenatide; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Sabine Arnolds, MD

  Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 3, 2009
• First Posted: September 4, 2009
• Study Start: January 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: November 1, 2008
• Last Updated: September 4, 2009

Record last verified: 2009-09

Locations

DE (1)