Randomized, Double-blind, Active-controlled, Study of Rivoglitazone in Type 2 Diabetes Mellitus

NCT00571519 | Terminated Phase 3 Results DMC

• 1 other identifier: CS0011-A-U302
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 18

Brief Summary

This is a 26-week, multicenter, randomized, double-blind, placebo and active comparator-controlled, parallel-group study in participants with type 2 diabetes currently sub-optimally controlled by diet and exercise or with non-thiazolidinedione antihyperglycemic monotherapy. Pioglitazone is used as active comparator. The total duration of a participant's participation will be approximately 30 weeks, including a 2-week placebo lead-in period, a 26-week double-blind treatment period, and a 2-week post-treatment follow-up period. Participants who complete the randomized portion of the study per protocol may have the opportunity to continue in a long-term extension study of active treatments.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in A1c From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus

  Glycosylated hemoglobin (A1c) levels and mean changes in A1c were used to measure glycemic control. A1c categorical targets are \<7.0% and \<6.5%.

  Baseline up to week 2, week 4, week 6, week 8, week 10, week 12, week 16, and week 20 post-dose.

Secondary Outcomes (14)

• Change in Fasting Plasma Glucose From Baseline Through Week 20 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus

  Baseline up to week 2, week 4, week 6, week 8, week 12, week 16, and week 20 post-dose.

• Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus

  Baseline up to week 12 post-dose.

• Percent Change in Total Cholesterol From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus

  Baseline up to week 12 post-dose.

• Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus

  Baseline up to week 12 post-dose.

• Percent Change in Total Triglycerides From Baseline Through Week 12 Following Rivoglitazone Compared to Pioglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus

  Baseline up to week 12 post-dose.

Study Arms (8)

1

EXPERIMENTAL

rivoglitazone HCl 0.5mg

Drug: Rivoglitazone HCl; Drug: metformin

2

EXPERIMENTAL

rivoglitazone HCl 1.0 mg

Drug: rivoglitazone HCl; Drug: metformin

3

EXPERIMENTAL

rivoglitazone HCl 1.5 mg

Drug: rivoglitazone HCl; Drug: metformin

4

PLACEBO COMPARATOR

placebo matching rivoglitazone HCl tablets

Drug: placebo; Drug: metformin

5

ACTIVE COMPARATOR

pioglitazone HCl 15 mg

Drug: pioglitazone HCl; Drug: metformin

6

ACTIVE COMPARATOR

pioglitazone HCl 30 mg

Drug: pioglitazone HCl; Drug: metformin

7

ACTIVE COMPARATOR

pioglitazone HCl 45 mg

Drug: pioglitazone HCl 45 mg; Drug: metformin

8

PLACEBO COMPARATOR

matching placebo for pioglitazone

Drug: placebo; Drug: metformin

Interventions

rivoglitazone HCl DRUG

0.5 mg tablets administered orally, once daily

Also known as: CS-011

1

placebo DRUG

placebo tablets matching rivoglitazone tablets administered orally, once daily

4

pioglitazone HCl DRUG

15 mg capsules administered orally, once daily

5

pioglitazone HCl 45 mg DRUG

45 mg capsules administered orally, once daily

7

metformin DRUG

Oral tablets. Rescue medication.

1; 2; 3; 4; 5; 6; 7; 8

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provided written informed consent at screening.
• Diagnosed with type 2 diabetes mellitus.
• Glycosylated hemoglobin (A1c) \>7.0% and ≤8.5% at screening.
• Male or female ≥18 years of age.
• Women of childbearing potential must have been using an adequate method of contraception to avoid pregnancy throughout the study, and for up to 4 weeks after study completion.
• Fasting C-peptide level \>0.5 ng/mL at screening.
• Currently being treated with a stable dose of an approved non-thiazolidinedione antihyperglycemic medication (including sulfonylureas, meglitinides, insulin secretagogues, metformin, or α-glucosidase inhibitors) given as monotherapy, for at least 3 months prior to screening, and could discontinue that antihyperglycemic medication at Visit 2 (Week -2) and for the duration of the study. OR
• Untreated and had not taken any antihyperglycemic agent during the 2 months prior to screening; if not treated with an oral antihyperglycemic agent, the participant was considered by the investigator to have failed diet and exercise modification as the sole treatment for type 2 diabetes mellitus.
• Clinically stable in regard to medical conditions other than type 2 diabetes mellitus.
• Concomitant medications (other than oral antihyperglycemic agents) were at stable doses for at least 30 days prior to enrollment and were not anticipated to need adjustment during the study period.

You may not qualify if:

• History of type 1 diabetes and/or history of ketoacidosis.
• History of long-term (\>2 months) therapy with insulin.
• History of prior treatment failure with, or intolerance of, a thiazolidinedione (ie, rosiglitazone, troglitazone, or pioglitazone).
• Treatment with a fibrate lipid-lowering agent (eg, fenofibrate, gemfibrozil).
• Confirmed repeat fasting glucose (≥2 readings of fasting blood glucose) \>240 mg/dL (13.3 mmol/L) during the 2-week washout/stabilization and placebo run-in period (Period A).
• Body mass index (BMI) \>45 kg/m2 at screening.
• History of weight loss \>10% over the 3 months prior to screening.
• Female participant who was pregnant or breastfeeding.
• Systolic blood pressure ≥180 mmHg and/or diastolic blood pressure
• ≥110 mmHg.
• Any known history of congestive heart failure prior to screening.
• Impaired liver function including evidence of acute or chronic hepatitis or liver disease by medical history, clinical signs or symptoms, or laboratory results.
• Evidence for ongoing infectious liver disease with positive hepatitis A antigen or immunoglobulin M antibody, hepatitis B surface antigen, or antibodies to hepatitis C virus. Participants with normal liver function tests and isolated positive antibodies to hepatitis B virus could have been included.
• Known (or evidence of) infection with human immunodeficiency virus.
• Known hemoglobinopathy or chronic anemia that required specific treatment within 5 years of the screening visit.

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (18)

Unknown Facility

Huntsville, Alabama, 35801, United States

Location

Unknown Facility

Huntsville, Alabama, 35802, United States

Location

Unknown Facility

San Diego, California, 92128, United States

Location

Unknown Facility

San Francisco, California, 94115, United States

Location

Unknown Facility

Ridgefield, Connecticut, 06877, United States

Location

Unknown Facility

Fort Lauderdale, Florida, 33308, United States

Location

Unknown Facility

Pembroke Pines, Florida, 33026, United States

Location

Unknown Facility

Port Gibson, Mississippi, 39150, United States

Location

Unknown Facility

Las Vegas, Nevada, 89119, United States

Location

Unknown Facility

Albuquerque, New Mexico, 87109, United States

Location

Unknown Facility

Kettering, Ohio, 45429, United States

Location

Unknown Facility

Fleetwood, Pennsylvania, 19522, United States

Location

Unknown Facility

Harrisburg, Pennsylvania, 17112, United States

Location

Unknown Facility

Simpsonville, South Carolina, 29681, United States

Location

Unknown Facility

Daingerfield, Texas, 75638, United States

Location

Unknown Facility

Dallas, Texas, 75216, United States

Location

Unknown Facility

Plano, Texas, 75093, United States

Location

Unknown Facility

San Antonio, Texas, 78205, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Pioglitazone; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines

Results Point of Contact

• Title: Contact for Clinical Trial Information
• Organization: Daiichi Sankyo

CTRinfo@dsi.com

908-992-6400

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2007
• First Posted: December 12, 2007
• Study Start: November 14, 2007
• Primary Completion: May 23, 2008
• Study Completion: May 23, 2008
• Last Updated: May 26, 2021
• Results First Posted: February 26, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)