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Study of Rivoglitazone in Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00484198
Recruitment Status : Completed
First Posted : June 8, 2007
Results First Posted : July 27, 2021
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Tracking Information
First Submitted Date  ICMJE June 7, 2007
First Posted Date  ICMJE June 8, 2007
Results First Submitted Date  ICMJE June 1, 2021
Results First Posted Date  ICMJE July 27, 2021
Last Update Posted Date July 27, 2021
Actual Study Start Date  ICMJE April 23, 2007
Actual Primary Completion Date February 12, 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2021)
  • Hemoglobin A1c at Baseline and Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [ Time Frame: Baseline up to week 26 post-dose ]
    Percentage of hemoglobin A1c (HbA1c) levels are reported.
  • Change in Hemoglobin A1c From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [ Time Frame: Baseline up to 26 weeks post-dose ]
    Percent change in hemoglobin (HbA1c) levels are reported. Greater (negative) percent change indicates improvement.
Original Primary Outcome Measures  ICMJE
 (submitted: June 7, 2007)
Glycemic control - HbA1c [ Time Frame: 26 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2021)
  • Fasting Plasma Glucose From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [ Time Frame: Baseline up to week 26 post-dose ]
    Normal fasting plasma glucose (FPG) levels are being reported. Normal FPG levels range from 70-110 mg/dL. Lower FPG values indicates better clinical outcome, ie. improvement in FPG.
  • Change in Fasting Plasma Glucose From Baseline Through Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [ Time Frame: Baseline up to 26 weeks post-dose ]
    The change in normal fasting plasma glucose (FPG) levels are being reported. A greater (negative) change from baseline indicates an improvement in FPG.
  • Homeostasis Model Assessment Index for Insulin Resistance At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [ Time Frame: Baseline up to week 26 post-dose ]
    Homeostasis Model Assessment index for Insulin Resistance (HOMA-IR) was calculated as: (fasting insulin concentration [μU/mL] x fasting glucose concentration [mmol/L])/22.5 Low HOMA-IR scores indicate high insulin sensitivity, whereas high HOMA-IR scores indicate low insulin sensitivity (insulin resistance). A normal HOMA-IR score is <2.60, HOMA-IR scores 2.60-3.80 are considered "borderline high", and HOMA-IR scores >3.80 are considered "high" and have correlations of insulin resistance. High HOMA-IR scores indicate worse outcome.
  • Change in Homeostasis Model Assessment Index for Insulin Resistance At Baseline To Week 26 Endpoint With Last Observation Carried Forward Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [ Time Frame: Baseline up to 26 weeks post-dose ]
    The change in the Homeostasis Model Assessment index for Insulin Resistance (HOMA-IR) was calculated as: (fasting insulin concentration [μU/mL] x fasting glucose concentration [mmol/L])/22.5 Low HOMA-IR scores indicate high insulin sensitivity, whereas high HOMA-IR scores indicate low insulin sensitivity (insulin resistance). A normal HOMA-IR score is <2.60, HOMA-IR scores 2.60-3.80 are considered "borderline high", and HOMA-IR scores >3.80 are considered "high" and have correlations of insulin resistance. A negative HOMA-IR score indicates an improvement in insulin sensitivity.
  • Total Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [ Time Frame: Baseline up to week 26 post-dose ]
    Total cholesterol is a measure of the total amount of cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C) - the "bad" cholesterol, high-density lipoprotein cholesterol (HDL-C) - the "good" cholesterol, and triglycerides. The equation to calculate total cholesterol is: LDL + HDL + (triglycerides/5) = total cholesterol.
  • Percent Change in Total Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [ Time Frame: Baseline up to 26 weeks post-dose ]
    Total cholesterol is a measure of the total amount of cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C) - the "bad" cholesterol, high-density lipoprotein cholesterol (HDL-C) - the "good" cholesterol, and triglycerides. The equation to calculate total cholesterol is: LDL + HDL + (triglycerides/5) = total cholesterol. Higher percent change in total cholesterol indicates better outcome, ie. improvement.
  • Total Triglycerides At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [ Time Frame: Baseline up to Week 26 post-dose ]
    Total Triglycerides (TG) is a measure of the total amount of triglycerides in the blood. The equation to calculate total triglycerides is: (total cholesterol-Low-density Lipoprotein cholesterol (LDL- C) - High-density lipoprotein cholesterol (HDL- C)) x 5 = Total Triglycerides. Normal triglyceride levels are below 150 mg/dL.
  • Percent Change in Total Triglycerides From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [ Time Frame: Baseline up to 26 weeks post-dose ]
    Total Triglycerides (TG) is a measure of the total amount of triglycerides in the blood. The equation to calculate total triglycerides is: (total cholesterol-Low-density Lipoprotein cholesterol (LDL- C) - High-density lipoprotein cholesterol (HDL- C)) x 5 = Total Triglycerides. A negative change means better outcome, ie. improvement.
  • Low-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [ Time Frame: Baseline up to Week 26 post-dose ]
    Low-density lipoprotein cholesterol (LDL-C), "bad" cholesterol, is a measure of the total amount of low-density lipoprotein cholesterol in the blood. Normal LDL levels are <100 mg/dL.
  • Percent Change in Low-Density Lipoprotein Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [ Time Frame: Baseline up to 26 weeks post-dose ]
    Low-density lipoprotein cholesterol (LDL-C), "bad" cholesterol, is a measure of the total amount of low-density lipoprotein cholesterol in the blood. A higher percent change indicates improvement.
  • High-Density Lipoprotein Cholesterol At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [ Time Frame: Baseline to Week 26 post-dose ]
    High-density lipoprotein cholesterol (HDL-C), "good" cholesterol, is a measure of the total amount of high-density lipoprotein cholesterol in the blood. Normal HDL levels are >40 mg/dL.
  • Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [ Time Frame: Baseline to 26 weeks post-dose ]
    High-density lipoprotein cholesterol (HDL-C), "good" cholesterol, is a measure of the total amount of high-density lipoprotein cholesterol in the blood. A higher percent change indicates improvement.
  • Apolipoprotein A-I At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [ Time Frame: Baseline to Week 26 post-dose ]
    Apolipoprotein (Apo) A-I levels, a measure of the total amount of Apolipoprotein (Apo) A-I in the blood, are being reported. Normal Apo A-1 levels range from 120-140 mg/dL.
  • Percent Change in Apolipoprotein A-I From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [ Time Frame: Baseline up to 26 weeks post-dose ]
    Apolipoprotein (Apo) A-I is a measure of the total amount of Apolipoprotein (Apo) A-I in the blood. Decreased ApoA-1 levels are associated with poor clinical outcome. A lower percent change in ApoA-1 levels indicates an improvement in clinical outcome.
  • Apolipoprotein B At Baseline To Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [ Time Frame: Baseline to Week 26 post-dose ]
    Apolipoprotein (Apo) B, a measure of the total amount of Apo B in the blood, is being reported. Normal Apo B levels are <100 mg/dL.
  • Percent Change in Apolipoprotein B From Baseline to Week 26 Endpoint With Last Observation Carried Forward (LOCF) Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [ Time Frame: Baseline up to 26 weeks post-dose ]
    Apolipoprotein (Apo) B, a measure of the total amount of Apo B in the blood, is being reported. A greater (negative) percent change in ApoB levels indicated an improvement in clinical outcome.
  • Hemoglobin A1c at Baseline and Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [ Time Frame: Baseline up to Week 52 post-dose ]
    Percentage of hemoglobin A1c (HbA1c) levels are reported.
  • Change in Hemoglobin A1c From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [ Time Frame: Baseline up to 52 weeks post-dose ]
    Change in hemoglobin (HbA1c) levels are reported. Greater (negative) percent change indicates improvement.
  • Fasting Plasma Glucose From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [ Time Frame: Baseline up to Week 52 post-dose ]
    Normal fasting plasma glucose (FPG) levels are being reported. Normal FPG levels range from 70-110 mg/dL. Lower FPG values indicates better clinical outcome, ie. improvement in FPG.
  • Change in Fasting Plasma Glucose From Baseline Through Week 52 Extension Period Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [ Time Frame: Baseline up to 52 weeks post-dose ]
    The change in normal fasting plasma glucose (FPG) levels are being reported. A greater (negative) change from baseline indicates an improvement in FPG.
  • Drug-Related Treatment-Emergent Adverse Events Reported by ≥1% Participants Following Rivoglitazone or Pioglitazone Compared to Placebo as Monotherapy Treatment of Type 2 Diabetes Mellitus [ Time Frame: Week -2 up to Week 52 post-dose ]
    Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred on or after the first dose of double-blind study medication, and ongoing AEs that started prior to the first dose of double-blind study medication and increased in severity on or after the first dose of double-blind study medication.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2007)
Glycemic control - FPG Responder rates - A1C Effects on lipid parameters
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Rivoglitazone in Type 2 Diabetes Mellitus
Official Title  ICMJE A Randomized, Double-blind, Placebo and Active Comparator-Controlled, Parallel-Group Study of the Efficacy and Safety of Rivoglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus
Brief Summary This is a 26-week study in subjects with type 2 diabetes currently sub-optimally controlled by diet and exercise or with non-thiazolidinedione antihyperglycemic monotherapy. The total duration of a subject's participation will be approximately 30 weeks, including a 2-week placebo run-in period, a 26-week double-blind treatment period, and a 2-week post-treatment follow-up period.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Pioglitazone
    45 mg over-encapsulated tablet administered orally, once daily
    Other Name: Actos
  • Drug: Placebo
    Rivoglitazone-matching placebo administered as a tablet orally, once daily or a pioglitazone-matching placebo administered as an over-encapsulated tablet orally, once daily capsule
  • Drug: Rivoglitazone
    1.0 mg tablet administered orally, once daily
  • Drug: Rivoglitazone
    1.5 mg tablet administered orally, once daily
Study Arms  ICMJE
  • Placebo Comparator: 1
    Intervention: Drug: Placebo
  • Experimental: 2
    Rivoglitazone 1.0 mg
    Intervention: Drug: Rivoglitazone
  • Experimental: 3
    Rivoglitazone 1.5 mg
    Intervention: Drug: Rivoglitazone
  • Active Comparator: 4
    Pioglitazone 45 mg
    Intervention: Drug: Pioglitazone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 6, 2021)
1912
Original Estimated Enrollment  ICMJE
 (submitted: June 7, 2007)
1820
Actual Study Completion Date  ICMJE February 12, 2009
Actual Primary Completion Date February 12, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of type 2 diabetes
  • Male or female at least 18 years of age
  • Hemoglobin A1C > 7% and less or equal to 8.5%
  • Non-fasting C-peptide > 0.5 ng/mL
  • Current monotherapy treatment with stable dose of approved non-Thiazolidinedione (TZD) antihyperglycemic medication for greater or equal to 3 months prior to screening or
  • Untreated with any antihyperglycemic agent during 2 months prior to screening

Exclusion Criteria:

  • History of type 1 diabetes or ketoacidosis
  • History of long-term therapy with insulin
  • Body Mass Index (BMI) > 45 kg/m^2
  • Known history of Congestive Heart Failure (CHF)
  • Impaired hepatic function
  • History of prior treatment failure with, or intolerance of, a TZD
  • Contraindication to treatment with pioglitazone
  • Treatment with fibrates
  • If untreated with oral antihyperglycemic, considered to have failed diet and exercise modification as the sole treatment for type 2 diabetes
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Austria,   Chile,   Czechia,   Germany,   Hungary,   India,   Latvia,   Mexico,   Peru,   Puerto Rico,   Romania,   Serbia,   Slovakia,   South Africa,   Ukraine,   United Kingdom,   United States
Removed Location Countries Czech Republic,   Former Serbia and Montenegro
 
Administrative Information
NCT Number  ICMJE NCT00484198
Other Study ID Numbers  ICMJE CS0011-A-U301
2006-005047-28 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Daiichi Sankyo, Inc.
Study Sponsor  ICMJE Daiichi Sankyo, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Leader Daiichi Sankyo, Inc.
PRS Account Daiichi Sankyo, Inc.
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP