A Study of RO5093151 and RO5027838 in Patients With Type 2 Diabetes Mellitus on a Stable Dose of Metformin

Diabetes Mellitus Type 2 Clinical Trial

Official title:

Multi-center, Randomized, Double-blind, 5-arm Parallel Group, Placebo Controlled 4 Week Study to Investigate the Safety, Tolerability and Efficacy of Two Doses Each (Near to Maximum Tolerated Dose and Lower Dose) of RO5093151 Administered Twice Daily (BID Regimen) and RO5027838 Administered Once da

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00823680
• Other study ID #: BP21850
• Secondary ID: 2008-001122-13
• Status: Completed
• Phase: Phase 2
• First received: January 15, 2009
• Last updated: July 26, 2016
• Start date: April 2009
• Est. completion date: August 2009

Study information

• Verified date: July 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 5 arm study will evaluate the efficacy and safety of RO5093151 and RO5027838 in patients with type 2 diabetes mellitus on a stable dose of metformin. After a 4 week pre-randomization period for glucose control, patients will be randomized to one of 5 groups to receive a)RO5093151 400mg po bid b)RO5093151 10mg po bid c)RO5027838 200mg po qd d)RO5027838 50mg po qd or e)placebo po bid for 4 weeks. The anticipated time on study treatment is < 3 months, and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

Inclusion Criteria:

• adult patients, 35-65 years of age;

• type 2 diabetes for >=3 months;

• treated for >=3 months with stable dose of metformin >=1.5g/day or maximum tolerated dose.

Exclusion Criteria:

• history of diabetic ketoacidosis;

• currently or previously treated with insulin;

• currently or within previous 6 months treated with a thiazolidinedione or dual peroxisome proliferator activated receptor (PPAR) agonist;

• treated with lipoprotein-modifying therapy within a month before screening.

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:
• Placebo
po bid for 4 weeks
• RO5027838
200mg po qd for 4 weeks
• RO5027838
50mg po bid for 4 weeks
• RO5093151
400mg po bid for 4 weeks
• RO5093151
10mg po bid for 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change in mean daily plasma glucose		From baseline to day 27	No
Secondary	Fasting plasma glucose		Baseline, and weeks 1, 2, 3 and 4	No
Secondary	Post-prandial glucose and insulin		Baseline, weeks 2 and 4	No
Secondary	Insulin sensitivity, beta cell function, lipid profile, HbA1C		At baseline, and at planned visits up to week 4	No
Secondary	Adverse events, lab parameters, vital signs, body weight		At baseline, and at planned visits up to week 4	No