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OpenTrials
Completed

NCT Number: NCT00800176

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

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

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Adelaide, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

po daily for 12 weeks

RO4998452

Drug

2.5mg po daily for 12 weeks

Primary outcomes

  1. Absolute Change in HbA1c

    Time frame: Baseline, Week 4, Week 8 and Week 12

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Dec 2, 2008
Registry last updated
Nov 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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