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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00111670
• Other study ID #: BM18102
• Status: Completed
• Phase: Phase 2
• First received: May 24, 2005
• Last updated: November 1, 2016
• Start date: June 2005
• Est. completion date: July 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 compared to placebo in patients with type 2 diabetes. The anticipated time on study treatment is < 3 months and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: July 2006
• Est. primary completion date: July 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 diagnosed >=1 month before screening;

• no previous treatment, or previous treatment with no more than 2 oral medications.

Exclusion Criteria:

• type 1 diabetes;

• type 2 diabetes treated with insulin or a PPAR gamma agonist during the 3 months before screening;

• patients who are pregnant, breastfeeding or not using a reliable contraceptive method.

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 or qd
• Placebo
po bid or qd

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Bulgaria,  Costa Rica,  Estonia,  Latvia,  Lithuania,  Mexico,  Puerto Rico,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change from baseline in HbAlc\n\n		Week 12	No
Secondary	Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, lipid profile, response rate		Week 12	No
Secondary	AEs, vital signs, laboratory tests, body weight, waist/hip ratio, ECG\n		Throughout study	No