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Trial · NCT01263470

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange From Baseline in Glycosylated Hemoglobin (Week 12).Baseline and Week 12.
Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
percentage of Glycosylated HemoglobinMEAN
SECONDARYChange From Baseline in Glycosylated Hemoglobin (Week 2).Baseline and Week 2.
Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
percentage of Glycosylated HemoglobinMEAN
SECONDARYChange From Baseline in Glycosylated Hemoglobin (Week 4).Baseline and Week 4.
Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
percentage of Glycosylated HemoglobinMEAN
SECONDARYChange From Baseline in Glycosylated Hemoglobin (Week 8).Baseline and Week 8.
Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
percentage of Glycosylated HemoglobinMEAN
SECONDARYChange From Baseline in Fasting Plasma Glucose (Week 2).Baseline and Week 2
Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
mg/dLMEAN
SECONDARYChange From Baseline in Fasting Plasma Glucose (Week 4).Baseline and Week 4.
Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
mg/dLMEAN
SECONDARYChange From Baseline in Fasting Plasma Glucose (Week 8).Baseline and Week 8.
Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
mg/dLMEAN
SECONDARYChange From Baseline in Fasting Plasma Glucose (Week 12).Baseline and Week 12.
Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
mg/dLMEAN
SECONDARYChange From Baseline in Fasting C-peptide (Week 2).Baseline and Week 2.
Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
ng/mLMEAN
SECONDARYChange From Baseline in Fasting C-peptide (Week 4).Baseline and Week 4.
Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
ng/mLMEAN
SECONDARYChange From Baseline in Fasting C-peptide (Week 8).Baseline and Week 8.
Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
ng/mLMEAN
SECONDARYChange From Baseline in Fasting C-peptide (Week 12).Baseline and Week 12.
Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
ng/mLMEAN
SECONDARYChange From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value).Baseline and Week 12.
Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
mg/dLMEAN
SECONDARYChange From Baseline in Blood Glucose Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC (0-2)).Baseline and Week 12.
Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
mg·hr/dLMEAN
SECONDARYChange From Baseline in Insulin Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC(0-2)).Baseline and Week 12
Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
μU·hr/mLMEAN
SECONDARYChange From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2).Baseline and Week 12.
Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
ng·hr/mLMEAN
SECONDARYChange From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)).Baseline and Week 12
Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.
pg·hr/mLMEAN

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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