A Study of Taspoglutide in Type 2 Diabetic Patients

A Double-blind, Crossover, Randomized, Placebo-controlled Study to Investigate the Effect of Two Different Doses of Taspoglutide IRF Administered as Continuous Subcutaneous Infusion on First- and Second-phase Insulin Secretion in Type 2 Diabetic Patients

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00811460

Enrollment

Registered

2008-12-19

Start date

2008-11-30

Completion date

2009-08-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2

Brief summary

This crossover study will assess the effect of 2 doses of Taspoglutide on first- and second-phase insulin secretion in patients with type 2 diabetes. Patients will receive a continuous subcutaneous infusion of a)the Immediate Release Formulation (IRF)of Taspoglutide 300 micrograms/day for 2 days followed by Taspoglutide 800 micrograms/day for 2 days or b)saline placebo for 2+2 days. After a washout period of 10-15 days, patients will be crossed-over for further treatment;those receiving Taspoglutide in period 1 will receive placebo in period 2, and vice versa. On days 2 and 4 of each period, insulin secretion patterns will be assessed. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.

Interventions

DRUGtaspoglutide

300micrograms/day sc for 2 days

DRUGPlacebo

sc for 4 days

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* adult patients, 18-65 years of age; * type 2 diabetes mellitus; * treated with diet and exercise alone, or in combination with stable metformin for at least 3 months prior to screening.

Exclusion criteria

* type 1 diabetes mellitus; * type 2 diabetes duration of \<3 months; * treatment with any oral anti-hyperglycemic medication other than metformin monotherapy during last 3 months; * treatment with insulin for \>7 days within 6 months prior to screening.

Design outcomes

Primary

Measure	Time frame
Incremental area under insulin concentration time curve relative to basal insulin concentration	First 10 minutes after glucose bolus

Secondary

Measure	Time frame
Incremental area under insulin concentration time curve relative to basal insulin concentration	10-120 minutes after glucose bolus
Adverse events, laboratory parameters	Throughout study

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026