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CompletedNCT00432679Updated Dec 12, 2022Results posted

A Study Of BRL49653C For The Treatment Of Type 2 Diabetes (Combination Therapy With Sulfonyl Urea) -With Placebo Study

A Phase 3 interventional study of Rosiglitazone (BRL49653C) in Diabetes Mellitus, Type 2, sponsored by GlaxoSmithKline. Completed at 4 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-12-12.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled May 2006, registered Feb 2007).
Phase
Phase 3
Study type
Interventional
Enrollment
149
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

This study was designed to compare the efficacy and safety of BRL49653C versus placebo with concomitant use of sulfonyl urea (SU).

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • rosiglitazone
  • Avandia
  • type 2 diabetes mellitus
  • diabetes
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 149 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.

Browse GlaxoSmithKline studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with type 2 diabetes mellitus managed by SU will be candidate for this study. These candidates will be checked up on their clinical laboratory data, and must have adequate blood, liver and kidney function.

Exclusion criteria

Exclusion criteria:

  • Patient with serious cardiovascular disease or serious hepatic disease will not be eligible.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
149 participants (actual)

Study arms

  • Experimental
    arm 1

    study drug

    Drug: Rosiglitazone (BRL49653C)

Interventions

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 16 Weeks of Treatment in Rosiglitazone Group and Placebo Group

    Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. The full analysis set used which was defined as remaining after participant who infringed on the following events were excluded from the randomized participants, who did not take the investigational drug during or after the treatment period (amount of investigational drug taken was zero tablets) and who were not measured for HbA1c even once as the observation period Baseline value or in the treatment period (after the investigational drug was prescribed), or for whom the above were unavailable (including cases that the above were considered missing measurements due to a defective sample).

    Time frame: Baseline (Day 0) and Week 16

Secondary outcomes

  1. Change From Baseline After 16 Weeks of Treatment in Fasting Plasma Glucose (FPG)

    Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.

    Time frame: Baseline (Day 0) and Week 16

  2. Change From Baseline After 16 Weeks of Treatment in Fasting Insulin

    Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.

    Time frame: Baseline (Day 0) and Week 16

  3. Change From Baseline After 16 Weeks of Treatment in Fasting Proinsulin

    Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.

    Time frame: Baseline (Day 0) and Week 16

  4. Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

    Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.

    Time frame: Baseline (Day 0) and Week 16

  5. Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Beta-cell Function (HOMA-beta)

    Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.

    Time frame: Baseline (Day 0) and Week 16

  6. Change From Baseline After 16 Weeks of Treatment in Adiponectin

    Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.

    Time frame: Baseline (Day 0) and Week 16

  7. Change From Baseline After 16 Weeks of Treatment in Leptin and High Sensitivity C-reactive Protein (Hs-CRP)

    Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.

    Time frame: Baseline (Day 0) and Week 16

  8. Percentage of Participants With Changes in HbA1c and FPG Meeting Specified Criteria After 16 Weeks of Treatment

    The specified criteria for HbA1c was, if the decrease from the observation period Baseline value meets the following conditions: 1) decrease from the observation period Baseline value is 0.7% or more; 2) fell below 6.5%; 3) satisfied either 1 or 2 noted above. And for FPG was, if the decrease from the observation period Baseline value meets the following conditions: 1) decrease of 30 mg per decilliter or more from the observation period Baseline value; 2) fell below 126 mg per deciliter; 3) satisfied either 1 or 2 noted above.

    Time frame: Up to Week 16

07

Results

Posted Feb 8, 2019

Participant flow

From 19 April 2006 to 28 March 2007, total of 149 participants were randomized at 22 centers in Japan.

Participant flow — Overall Study
MilestoneRosiglitazone 4 mg Orally Once DailyPlacebo
Started7475
Completed6972
Not completed53
Withdrew: Adverse event21
Withdrew: Withdrawal by subject32

Outcome measures

PrimaryChange From Baseline in Glycosylated Hemoglobin (HbA1c) After 16 Weeks of Treatment in Rosiglitazone Group and Placebo Group

Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value. The full analysis set used which was defined as remaining after participant who infringed on the following events were excluded from the randomized participants, who did not take the investigational drug during or after the treatment period (amount of investigational drug taken was zero tablets) and who were not measured for HbA1c even once as the observation period Baseline value or in the treatment period (after the investigational drug was prescribed), or for whom the above were unavailable (including cases that the above were considered missing measurements due to a defective sample).

Time frame:
Baseline (Day 0) and Week 16
Reported as:
Mean · Percentage of Glycosylated Hemoglobin
Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 16 Weeks of Treatment in Rosiglitazone Group and Placebo Group
Percentage of Glycosylated HemoglobinRosiglitazone 4 mg Orally Once DailyPlacebo
Change From Baseline in Glycosylated Hemoglobin (HbA1c) After 16 Weeks of Treatment in Rosiglitazone Group and Placebo Group-0.62 ± 0.0740.19 ± 0.073
Statistical analysis
  • Rosiglitazone 4 mg Orally Once Daily vs Placebo · ANCOVA · p = <0.001 (Change from Baseline in HbA1c = Treatment+ Baseline HbA1c+ Gender+ body mass index (BMI)) · Mean difference (net): -0.81 · 95% CI -1.01 to -0.61
SecondaryChange From Baseline After 16 Weeks of Treatment in Fasting Plasma Glucose (FPG)

Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.

Time frame:
Baseline (Day 0) and Week 16
Reported as:
Mean · Mg per decilliter
Change From Baseline After 16 Weeks of Treatment in Fasting Plasma Glucose (FPG)
Mg per decilliterRosiglitazone 4 mg Orally Once DailyPlacebo
Change From Baseline After 16 Weeks of Treatment in Fasting Plasma Glucose (FPG)-15.9 ± 28.916.2 ± 32.69
Statistical analysis
  • Rosiglitazone 4 mg Orally Once Daily vs Placebo · Unpaired t-test · p = <0.001 · Mean difference (net): -22.1 · 95% CI -32.1 to -12.1
SecondaryChange From Baseline After 16 Weeks of Treatment in Fasting Insulin

Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.

Time frame:
Baseline (Day 0) and Week 16
Reported as:
Mean · Microunits per millilliter
Change From Baseline After 16 Weeks of Treatment in Fasting Insulin
Microunits per millilliterRosiglitazone 4 mg Orally Once DailyPlacebo
Change From Baseline After 16 Weeks of Treatment in Fasting Insulin-0.479 ± 3.2699-1.197 ± 6.1434
Statistical analysis
  • Rosiglitazone 4 mg Orally Once Daily vs Placebo · Unpaired t-test · p = 0.377 · Mean difference (net): 0.718 · 95% CI -0.883 to 2.319
SecondaryChange From Baseline After 16 Weeks of Treatment in Fasting Proinsulin

Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.

Time frame:
Baseline (Day 0) and Week 16
Reported as:
Mean · Picomoles per millilliter
Change From Baseline After 16 Weeks of Treatment in Fasting Proinsulin
Picomoles per millilliterRosiglitazone 4 mg Orally Once DailyPlacebo
Change From Baseline After 16 Weeks of Treatment in Fasting Proinsulin-1.64 ± 13.6300.40 ± 11.666
Statistical analysis
  • Rosiglitazone 4 mg Orally Once Daily vs Placebo · Unpaired t-test · p = 0.330 · Mean difference (net): -2.04 · 95% CI -6.18 to 2.09
SecondaryChange From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.

Time frame:
Baseline (Day 0) and Week 16
Reported as:
Mean · MilliUnit per liter*millimoles per liter
Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
MilliUnit per liter*millimoles per literRosiglitazone 4 mg Orally Once DailyPlacebo
Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)-0.496 ± 1.5562-0.486 ± 3.7556
Statistical analysis
  • Rosiglitazone 4 mg Orally Once Daily vs Placebo · Unpaired t-test · p = 0.983 · Mean difference (net): -0.010 · 95% CI -0.945 to 0.925
SecondaryChange From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Beta-cell Function (HOMA-beta)

Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.

Time frame:
Baseline (Day 0) and Week 16
Reported as:
Mean · Percentage of normal beta cells function
Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Beta-cell Function (HOMA-beta)
Percentage of normal beta cells functionRosiglitazone 4 mg Orally Once DailyPlacebo
Change From Baseline After 16 Weeks of Treatment in Homeostasis Model Assessment of Beta-cell Function (HOMA-beta)3.776 ± 18.7875-4.444 ± 24.0408
Statistical analysis
  • Rosiglitazone 4 mg Orally Once Daily vs Placebo · Unpaired t-test · p = 0.022 · Mean difference (net): 8.220 · 95% CI 1.191 to 15.248
SecondaryChange From Baseline After 16 Weeks of Treatment in Adiponectin

Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.

Time frame:
Baseline (Day 0) and Week 16
Reported as:
Mean · Micrograms per millilliter
Change From Baseline After 16 Weeks of Treatment in Adiponectin
Micrograms per millilliterRosiglitazone 4 mg Orally Once DailyPlacebo
Change From Baseline After 16 Weeks of Treatment in Adiponectin9.19 ± 7.0300.98 ± 2.301
Statistical analysis
  • Rosiglitazone 4 mg Orally Once Daily vs Placebo · Unpaired t-test · p = <0.001 · Mean difference (net): 8.21 · 95% CI 6.52 to 9.91
SecondaryChange From Baseline After 16 Weeks of Treatment in Leptin and High Sensitivity C-reactive Protein (Hs-CRP)

Baseline value was value on Day 0. Change from Baseline was defined as value at Week 16 minus Baseline value.

Time frame:
Baseline (Day 0) and Week 16
Reported as:
Mean · Nanograms per millilliter
Change From Baseline After 16 Weeks of Treatment in Leptin and High Sensitivity C-reactive Protein (Hs-CRP)
Nanograms per millilliterRosiglitazone 4 mg Orally Once DailyPlacebo
Leptin0.59 ± 2.751-0.07 ± 1.332
Hs-CRP-189.1 ± 5376.91699.7 ± 4349.58
Statistical analysis
  • Rosiglitazone 4 mg Orally Once Daily vs Placebo · Unpaired t-test · p = 0.069 · Mean difference (net): 0.65 · 95% CI -0.05 to 1.35Comparison of leptin.
  • Rosiglitazone 4 mg Orally Once Daily vs Placebo · Unpaired t-test · p = 0.271 · Mean difference (net): -888.8 · 95% CI -2477.7 to 700.1Comparison of hs-CRP
SecondaryPercentage of Participants With Changes in HbA1c and FPG Meeting Specified Criteria After 16 Weeks of Treatment

The specified criteria for HbA1c was, if the decrease from the observation period Baseline value meets the following conditions: 1) decrease from the observation period Baseline value is 0.7% or more; 2) fell below 6.5%; 3) satisfied either 1 or 2 noted above. And for FPG was, if the decrease from the observation period Baseline value meets the following conditions: 1) decrease of 30 mg per decilliter or more from the observation period Baseline value; 2) fell below 126 mg per deciliter; 3) satisfied either 1 or 2 noted above.

Time frame:
Up to Week 16
Reported as:
Number · Percentage of participants
Percentage of Participants With Changes in HbA1c and FPG Meeting Specified Criteria After 16 Weeks of Treatment
Percentage of participantsRosiglitazone 4 mg Orally Once DailyPlacebo
HbA1c, decrease by 0.7%44.64.0
HbA1c, fell below 6.5%6.80.0
HbA1c, satisfied either 1 or 244.64.0
FPG, decrease of 30 milligrams per decilliter31.18.0
FPG, fell below 126 milligrams per deciliter16.29.3
FPG, satisfied either 1 or 235.114.7
Statistical analysis
  • Rosiglitazone 4 mg Orally Once Daily vs Placebo · Mean difference (final values): 40.6 · 95% CI 27.1 to 54.1Comparison of HbA1c, decrease by 0.7%
  • Rosiglitazone 4 mg Orally Once Daily vs Placebo · Mean difference (final values): 6.8 · 95% CI -0.3 to 13.8Comparison of HbA1c, fell below 6.5%
  • Rosiglitazone 4 mg Orally Once Daily vs Placebo · Mean difference (final values): 40.6 · 95% CI 27.1 to 54.1Comparison of HbA1c, satisfied either 1 or 2
  • Rosiglitazone 4 mg Orally Once Daily vs Placebo · Mean difference (final values): 23.1 · 95% CI 9.5 to 36.6Comparison of FPG, decrease of 30 milligrams per decilliter
  • Rosiglitazone 4 mg Orally Once Daily vs Placebo · Mean difference (final values): 6.9 · 95% CI -5.1 to 18.9Comparison of FPG, fell below 126 milligrams per deciliter
  • Rosiglitazone 4 mg Orally Once Daily vs Placebo · Mean difference (final values): 20.5 · 95% CI 5.6 to 35.3Comparison of FPG, satisfied either 1 or 2

Adverse events

Collected over All adverse events (AE) and serious adverse events (SAE) were reported during the clinical trial period (from the observation period (Week -4) to the post-trial examination date (up to Week 18 or 2 weeks after the discontinuation).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Rosiglitazone 4 mg Orally Once Daily0/74 (0%)1/74 (1.4%)61/74 (82.4%)
Placebo0/75 (0%)1/75 (1.3%)53/75 (70.7%)
Most frequent serious events
Most frequent serious events
EventRosiglitazone 4 mg Orally Once DailyPlacebo
Liposacromal recurrentNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/740/75
Brain stem infarctionNervous system disorders0/741/75
Most frequent other events
Showing 10 of 122
Most frequent other events
EventRosiglitazone 4 mg Orally Once DailyPlacebo
NasopharyngitisInfections and infestations10/7412/75
Upper respiratory tract inflammationRespiratory, thoracic and mediastinal disorders8/7411/75
Weight increasedInvestigations10/741/75
Blood creatine phosphokinase increasedInvestigations9/743/75
Blood triglyccrides increasedInvestigations7/741/75
Oedema peripheralGeneral disorders6/740/75
Blood pressure increasedInvestigations2/744/75
Brain natriuretic peptide increasedInvestigations3/742/75
PharyngitisInfections and infestations3/743/75
DiarrhoeaGastrointestinal disorders3/741/75

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Rosiglitazone 4 mg Orally Once DailyPlaceboTotal
Mean60.1 ± 8.8161.6 ± 9.8060.8 ± 9.32
Sex: Female, Male
Sex: Female, Male(Participants)Rosiglitazone 4 mg Orally Once DailyPlaceboTotal
Female272855
Male474794
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Rosiglitazone 4 mg Orally Once DailyPlaceboTotal
American Indian or Alaska Native000
Asian7475149
Native Hawaiian or Other Pacific Islander000
Black or African American000
White000
More than one race000
Unknown or Not Reported000
08

Study locations

4 sites
  • GSK Investigational Site
    Kanagawa, 212-0024, Japan
  • GSK Investigational Site
    Kumamoto, 862-0976, Japan
  • GSK Investigational Site
    Ōita, 870-0039, Japan
  • GSK Investigational Site
09

References and documents

Publications

  • This study has not been published in the scientific literature.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00432679
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Feb 8, 2007
Start date
May 24, 2006
Primary completion
Mar 28, 2007
Completion
Mar 28, 2007
Results posted
Feb 8, 2019
Last update
Dec 12, 2022

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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