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A Dose-Finding Study of RO4998452 in Patients With Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00800176
Recruitment Status : Completed
First Posted : December 2, 2008
Results First Posted : November 18, 2020
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This 6 arm study will evaluate the efficacy, safety and pharmacokinetics of 5 doses of RO4998452 compared to placebo in patients with type 2 diabetes mellitus. Patients will be randomized to one of 6 groups to receive RO4998452 at doses of 2.5mg, 5mg, 10mg, 20mg or 40mg po daily, or placebo daily. Patients pre-treated with stable metformin will continue to take their usual dose of metformin throughout the study.The anticipated time on study treatment is <=3 months

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: Placebo Drug: RO4998452 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 394 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center, Double-blind, Randomized, Parallel Group, Placebo-controlled 12-week Study to Investigate Glycemic Parameters of Efficacy, Safety/ Tolerability and Pharmacokinetics of Five Dose Levels of RO4998452 in Patients With Type 2 Diabetes Mellitus
Actual Study Start Date : January 22, 2009
Actual Primary Completion Date : October 28, 2009
Actual Study Completion Date : October 28, 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo

During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast.

During the 12-week double-blind treatment period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test.

Drug: Placebo
po daily for 12 weeks

Experimental: RO4998452 10mg
During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.
Drug: RO4998452
10mg po daily for 12 weeks

Experimental: RO4998452 2.5mg
During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.
Drug: RO4998452
2.5mg po daily for 12 weeks

Experimental: RO4998452 20mg
During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.
Drug: RO4998452
20mg po daily for 12 weeks

Experimental: RO4998452 40mg
During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452.
Drug: RO4998452
40mg po daily for 12 weeks

Experimental: RO4998452 5mg
During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.
Drug: RO4998452
5mg po daily for 12 weeks




Primary Outcome Measures :
  1. Absolute Change in HbA1c [ Time Frame: Baseline, Week 4, Week 8 and Week 12 ]

Secondary Outcome Measures :
  1. Change From Baseline in Fasting Plasma Glucose (mmol/L) [ Time Frame: Baseline and Week 12 ]
  2. Change From Baseline in Mean Daily Glucose Concentration (mmol/L) [ Time Frame: Baseline and Week 12 ]
  3. Change From Baseline in Fructosamine Concentration (μmol/L) [ Time Frame: Baseline and 12 weeks ]
  4. Change From Baseline in Meal Tolerance Test: 0-3h Mean Glucose Concentration (mmol/L) [ Time Frame: Baseline and Week 12 ]
  5. Change From Baseline in Meal Tolerance Test: 0-3h Mean Insulin Concentration (mmol/L) [ Time Frame: Baseline and Week 12 ]
  6. Change From Baseline in Meal Tolerance Test: 0-3h Urinary Glucose Excretion (mmol/L) [ Time Frame: Baseline and Week 12 ]
  7. Change From Baseline in Body Weight (kg) [ Time Frame: Baseline and Week 12 ]
  8. Percentage of Participants Treated to Target HbA1c < 7% [ Time Frame: Baseline up to 12 weeks ]
  9. Percentage of Participants Treated to Target HbA1c < 6.5% [ Time Frame: Baseline up to 12 weeks ]
  10. Percentage of Participants With at Least One Adverse Event [ Time Frame: Baseline up to 12 weeks ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, 18-75 years of age;
  • type 2 diabetes, diagnosed for >=3 months;
  • either treated with diet, exercise and stable metformin, or with diet and exercise alone.

Exclusion Criteria:

  • type 1 diabetes mellitus;
  • currently or within 2 months prior to screening treated with an oral or injectable anti-diabetic agent except stable doses of metformin;
  • currently or within 6 months prior to screening treated with any PPARgamma agonist;
  • uncontrolled hypertension;
  • significant pre-diagnosed diabetic complications requiring treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00800176


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00800176    
Other Study ID Numbers: BC21587
2008-001249-24
First Posted: December 2, 2008    Key Record Dates
Results First Posted: November 18, 2020
Last Update Posted: November 18, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases