Trial · NCT01453049
An Efficacy and Safety Study of Fixed-dose Rosiglitazone/Glimepiride to Treat Chinese Type 2 Diabetes Patients
NCT01453049, Phase 3, Terminated, GlaxoSmithKline; results first posted 2012-01-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Efficacy and Safety Study of Fixed-dose Rosiglitazone/Glimepiride to Treat Chinese Type 2 Diabetes Patients. Trials, record NCT01453049. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01453049
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Efficacy and Safety Study of Fixed-dose Rosiglitazone/Glimepiride to Treat Chinese Type 2 Diabetes Patients
- NCT number
- NCT01453049
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 86 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- rosiglitazone/glimepiride fix dose combination, glimepiride
- First posted
- 2011-10-17
- Last updated
- 2012-03-27
- Results first posted
- 2012-01-13
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | Baseline (Week 0) and Week 24 | Blood samples of participants were collected for HbA1c assessment. HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The American Diabetes Association has recommended an HbA1c value below 53 millimoles per mole (mmol/mol) (7.0%) for most participants. Change from Baseline in HbA1c was calculated as the value at Week 24 minus the value at Baseline. |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Baseline (Week 0) and Week 24 | Blood samples of participants were collected for FPG assessment. The FPG test, also known as the fasting blood sugar test, measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. Change from Baseline in FBG was calculated as the value at Week 24 minus the value at Baseline. |
| Secondary | Number of HbA1c Responders and Non-responders | Baseline (Week 0) and Week 24 (LOCF) | Blood samples of participants were collected for HbA1c assessment. HbA1c responders were defined as participants who had achieved HbA1c \<7%, or who achieved a decrease of \>= 0.7% from Baseline at Week 24 (LOCF). |
| Secondary | Number of FPG Responders and Non-responders | Baseline (Week 0) and Week 24 (LOCF) | Blood samples of participants were collected for FPG assessment. FPG responders are definded as participants who had a \>=1.7 mmol/L decrease from Baseline FPG or who achieved a FPG level \< 6.1 mmol/L at Week 24 (LOCF). |
| Secondary | Number of Participants Who Achieved HbA1c <7%, HbA1c <=6.5%, or Who Achieved a Decrease of >=0.7% From Baseline | Baseline (Week 0) and Week 24 (LOCF) | Blood samples of participants were collected for HbA1c assessment. |
| Secondary | Change From Baseline in Fasting Proinsulin and Insulin at Week 24/Early Withdrawal (EW) | Baseline (Week 0) and Week 24/EW | Blood samples of participants who had fasted for 12-14 hours were collected for fasting proinsulin (precursor of insulin) and insulin assessment. Preproinsulin is sequentially processed via proinsulin, through intermediate proteolytic cleavage products, to insulin and C-peptide before release from the beta cell granule by exocytosis. Elevated levels of proinsulin are considered indicative of beta cell dysfunction. Insulin is a hormone that regulates carbohydrate and fat metabolism in the body. Change from Baseline was calculated as the value at Week 24/ EW minus the value at Baseline (Week 0). |
| Secondary | Change From Baseline in Homeostasis Model Assessment Sensitivity (HOMA-S) at Week 24/EW | Baseline (Week 0) and Week 24/EW | Blood samples of participants who had fasted for 12-14 hours were collected for fasting glucose (FG) and insulin (FI) assessment. The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance (a condition in which natural hormone insulin becomes less effective in lowering blood sugars) and beta-cell (specialized cells in the pancreas producing insulin) function. HOMA-S is calculated using the following model to predict glucose and insulin concentrations=(FI\[milliunits (mU)/milliliter (ml)\]\*FG \[millimoles per liter (mmol/l)\])/22.5. numerator, num.; denominator, denom. |
| Secondary | Change From Baseline in Homeostasis Model Assessment Beta-cell Function (HOMA-B) at Week 24/EW | Baseline (Week 0) and Week 24/EW | Blood samples of participants who had fasted for 12 to 14 hours were collected for fasting glucose (FG) and insulin (FI) assessment. The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance (a condition in which natural hormone insulin becomes less effective in lowering blood sugars) and beta-cell (specialized cells in the pancreas producing insulin) function. HOMA-B is calculated using the following mathematical model to predict glucose and insulin concentrations=(20\*FI\[mU/ml\])/(FG\[mmol/l\]-3.5). |
| Secondary | Number of Participants at Various Dose Levels at Week 24/EW | Week 24/EW | The number of participants at the different dose levels at Week 24/EW was recorded. The different dose levels for Rosi + Glim are: Dose level 1, Rosi 4 mg + Glim 1 mg; Dose level 2, Rosi 4 mg + Glim 2 mg; Dose level 3, Rosi 4 mg + Glim 4 mg. The different dose levels for Glim are: Dose level 1, Glim 1 mg; Dose level 2, Glim 2 mg; Dose level 3, Glim 4 mg. |
| Secondary | Change From Baseline in Total Cholesterol (TC), High Density Lipoprotein-cholesterol (HDL-C), Low Density Lipoprotein-cholesterol (LDL-C), and Triglyceride (TG) at Week 24/EW | Baseline (Week 0) and Week 24/EW | Blood samples of participants who had fasted for 12 to 14 hours were collected for lipid profile (TC, HDL-C, LDL-C, TG) assessment. The lipid profile asesses the risk of heart disease. Change from Baseline in TC, HDL-C, LDL-C, and TG was calculated as the value at Week 24)/EW minus the value at Baseline. |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | Baseline (Week 0) and Week 24 | Full Analysis Set (FAS): all randomized participants who received \>=1 dose of study medication and had \>=1 post-Baseline efficacy assessment. Missing values were imputed using Last Observation Carried Forward (used to estimate subsequent missing data points). Only those participants contributing data at the indicated time points were analyzed. | Percent of total hemoglobin | MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Baseline (Week 0) and Week 24 | FAS. Missing values were imputed using the Last Observation Carried Forward (LOCF) method, i.e., the last available observation was used to estimate subsequent missing data points. Only those participants contributing data at the indicated time points were analyzed. | Millimoles per liter (mmol/L) | MEAN |
| SECONDARY | Number of HbA1c Responders and Non-responders | Baseline (Week 0) and Week 24 (LOCF) | FAS. Missing values were imputed using the LOCF method, i.e., the last available observation was used to estimate subsequent missing data points. Only those participants contributing data at the indicated time points were analyzed. | participants | NUMBER |
| SECONDARY | Number of FPG Responders and Non-responders | Baseline (Week 0) and Week 24 (LOCF) | FAS. Missing values were imputed using the LOCF method, i.e., the last available observation was used to estimate subsequent missing data points. Only those participants contributing data at the indicated time points were analyzed. | participants | NUMBER |
| SECONDARY | Number of Participants Who Achieved HbA1c <7%, HbA1c <=6.5%, or Who Achieved a Decrease of >=0.7% From Baseline | Baseline (Week 0) and Week 24 (LOCF) | FAS. Missing values were imputed using the LOCF method, i.e., the last available observation was used to estimate subsequent missing data points. Only those participants contributing data at the indicated time points were analyzed. | participants | NUMBER |
| SECONDARY | Change From Baseline in Fasting Proinsulin and Insulin at Week 24/Early Withdrawal (EW) | Baseline (Week 0) and Week 24/EW | FAS. Only those participants contributing data at the indicated time points were analyzed. | Picomoles per liter (pmol/L) | MEAN |
| SECONDARY | Change From Baseline in Homeostasis Model Assessment Sensitivity (HOMA-S) at Week 24/EW | Baseline (Week 0) and Week 24/EW | FAS. Only those participants contributing data at the indicated time points were analyzed. | Ratio: FI*FG (num.); 22.5 (denom.) | MEAN |
| SECONDARY | Change From Baseline in Homeostasis Model Assessment Beta-cell Function (HOMA-B) at Week 24/EW | Baseline (Week 0) and Week 24/EW | FAS. Only those participants contributing data at the indicated time points were analyzed. | Ratio: 20*FI (num.); FG-3.5 (denom.) | MEAN |
| SECONDARY | Number of Participants at Various Dose Levels at Week 24/EW | Week 24/EW | FAS. Only those participants contributing data at the indicated time points were analyzed. Data were missing for one participant in the rosiglitazone+glimepiride FDC arm. | participants | NUMBER |
| SECONDARY | Change From Baseline in Total Cholesterol (TC), High Density Lipoprotein-cholesterol (HDL-C), Low Density Lipoprotein-cholesterol (LDL-C), and Triglyceride (TG) at Week 24/EW | Baseline (Week 0) and Week 24/EW | FAS. Only those participants contributing data at the indicated time points were analyzed. | mmol/L | MEAN |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 outcomesResults by group150
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | Rosiglitazone+Glimepiride FDC | -1.75 | Standard Deviation 1.078 | Percent of total hemoglobin | |
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | Glimepiride | -1.47 | Standard Deviation 1.227 | Percent of total hemoglobin | |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Rosiglitazone+Glimepiride FDC | -1.907 | Standard Deviation 2.9601 | Millimoles per liter (mmol/L) | |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Glimepiride | -0.877 | Standard Deviation 2.0673 | Millimoles per liter (mmol/L) | |
| Number of HbA1c Responders and Non-responders | Rosiglitazone+Glimepiride FDC | Responders | 33 | participants | |
| Number of HbA1c Responders and Non-responders | Glimepiride | Responders | 29 | participants | |
| Number of HbA1c Responders and Non-responders | Rosiglitazone+Glimepiride FDC | Non-responders | 2 | participants | |
| Number of HbA1c Responders and Non-responders | Glimepiride | Non-responders | 9 | participants | |
| Number of FPG Responders and Non-responders | Rosiglitazone+Glimepiride FDC | Responders | 21 | participants | |
| Number of FPG Responders and Non-responders | Glimepiride | Responders | 12 | participants |
1 to 10 of 150Source ClinicalTrials.gov
See all 150 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rosiglitazone+Glimepiride FDC | 42 | |
| Overall Study | STARTED | Glimepiride | 44 | |
| Overall Study | COMPLETED | Rosiglitazone+Glimepiride FDC | 1 | |
| Overall Study | COMPLETED | Glimepiride | 2 | |
| Overall Study | NOT COMPLETED | Rosiglitazone+Glimepiride FDC | 41 | |
| Overall Study | NOT COMPLETED | Glimepiride | 42 |
Source ClinicalTrials.gov
Adverse events34
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hyperlipidemia | Metabolism and nutrition disorders | Rosiglitazone+Glimepiride FDC | 1 | 40 | |
| other | Hyperlipidemia | Metabolism and nutrition disorders | Glimepiride | 1 | 43 | |
| other | Hypocalcemia | Metabolism and nutrition disorders | Rosiglitazone+Glimepiride FDC | 0 | 40 | |
| other | Hypocalcemia | Metabolism and nutrition disorders | Glimepiride | 1 | 43 | |
| other | Hypokalemia | Metabolism and nutrition disorders | Rosiglitazone+Glimepiride FDC | 0 | 40 | |
| other | Hypokalemia | Metabolism and nutrition disorders | Glimepiride | 1 | 43 | |
| other | Constipation | Gastrointestinal disorders | Rosiglitazone+Glimepiride FDC | 0 | 40 | |
| other | Constipation | Gastrointestinal disorders | Glimepiride | 1 | 43 | |
| other | Gastroenteritis | Gastrointestinal disorders | Rosiglitazone+Glimepiride FDC | 1 | 40 | |
| other | Gastroenteritis | Gastrointestinal disorders | Glimepiride | 0 | 43 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rosiglitazone+Glimepiride FDC | ||
| Total, all-cause mortality | Glimepiride | ||
| Total, other adverse events | Rosiglitazone+Glimepiride FDC | 6 | 40 |
| Total, other adverse events | Glimepiride | 10 | 43 |
| Total, serious adverse events | Rosiglitazone+Glimepiride FDC | 0 | 40 |
| Total, serious adverse events | Glimepiride | 0 | 43 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rosiglitazone+Glimepiride FDC vs Glimepiride: Number of Participants With a Bone Fracture | Trial comparisons |
| Rosiglitazone+Glimepiride FDC vs Glimepiride: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01453049
GET https://conductscience.org/api/trials/v1/NCT01453049/registered?page=2