A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes

Diabetes Mellitus Type 2 Clinical Trial

Official title:

A Randomized, Double-blind Study of the Effect of the DPP-IV Inhibitor on HbA1c and Safety in Patients With Type 2 Diabetes Treated With a Stable Dose of Metformin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00111631
• Other study ID #: BM18106
• Status: Completed
• Phase: Phase 2
• First received: May 24, 2005
• Last updated: November 1, 2016
• Start date: May 2005
• Est. completion date: October 2006

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor in patients with type 2 diabetes receiving a stable dose of metformin. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• adult patients 18-75 years of age;

• type 2 diabetes;

• stable metformin therapy for >=3 months before screening.

Exclusion Criteria:

• women who are pregnant, breast-feeding, or not using an adequate contraceptive method;

• type 1 diabetes;

• any anti-hyperglycemic medication other than metformin in the last 3 months.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• DPP-IV Inhibitor
Escalating doses po bid
• Metformin
As prescribed
• Placebo
po bid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Italy,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change from baseline in HbAlc\n		Week 16	No
Secondary	Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, and lipid profile, response rate\n		Week 16	No
Secondary	AEs, vital signs, laboratory tests, body weight, waist/hip ratio, ECG\n		Throughout study	No