A Multiple Ascending Dose Study of RO4998452 in Patients With Type 2 Diabetes Mellitus.

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00682097
• Collaborator: (none)
• Enrollment: 55
• Locations: 3
• Arms: 7
• Duration (Months): 10
• Patients Per Site: 18.3
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of RO4998452 compared to placebo in patients with type 2 diabetes mellitus. Successive cohorts of patients will be randomized to receive either active drug, at escalating doses, or placebo. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Type 2	Drug: RO4998452; Drug: placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Multiple-Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO4998452 Following Oral Administrations in Patients With Type 2 Diabetes Mellitus
• Study Start Date: May 1, 2008
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: RO4998452; Escalating oral doses; Drug: placebo; Oral doses
Experimental: 2	Drug: RO4998452; Escalating oral doses; Drug: placebo; Oral doses
Experimental: 3	Drug: RO4998452; Escalating oral doses; Drug: placebo; Oral doses
Experimental: 4	Drug: RO4998452; Escalating oral doses; Drug: placebo; Oral doses
Experimental: 5	Drug: RO4998452; Escalating oral doses; Drug: placebo; Oral doses
Experimental: 6	Drug: RO4998452; Escalating oral doses; Drug: placebo; Oral doses
Experimental: 7	Drug: RO4998452; Escalating oral doses; Drug: placebo; Oral doses

Outcome Measures

Primary Outcome Measures

1. AEs, laboratory parameters, vital signs. [Throughout study]

2. AUC0-24h, Cmax [Days 1 and 14]

Secondary Outcome Measures

1. Parameters of glucose metabolism [Throughout study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• adult patients, 18-65 years of age;

• type 2 diabetes;

• either treated by diet and exercise alone or with metformin.

Exclusion Criteria:

• type 1 diabetes mellitus;

• uncontrolled hypertension;

• clinically severe diabetic complications.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Chula Vista	California	United States	91911
2		San Antonio	Texas	United States	78229
3		Neuss		Germany	41460

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT00682097
• Other Study ID Numbers: BP21549; 2007-007120-18
• First Posted: May 22, 2008
• Last Update Posted: Nov 2, 2016
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Nov 2, 2016