Trial · NCT02730377
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Inadequate Glycaemic Control | Weeks 26-104 | Inadequate glycaemic control was defined as glycosylated haemoglobin (HbA1c) of 7.0% (53 mmol/mol) or greater at two consecutive visits after the first 26 weeks of treatment and up to 104 weeks. 25%, median (50%) and 75% percentiles for the cumulative distribution function, are obtained from the Kaplan-Meier survival function. HbA1c was recorded at weeks 38, 52, 65, 78, 91 and 104. |
| Secondary | Time to Premature Treatment Discontinuation (for Any Reason Including Inadequate Glycaemic Control) | Weeks 0-104 | The time to premature treatment discontinuation (for any reason including inadequate glycaemic control) was analysed and presented using the generalised log rank test. 25%, median (50%) and 75% percentiles for the cumulative distribution function, are obtained from the Kaplan-Meier survival function. |
| Secondary | Change in HbA1c | Week 0, week 104/premature treatment discontinuation | Change from baseline (week 0) in HbA1c at week 104 or at premature treatment discontinuation is presented. |
| Secondary | Participants Who Achieve HbA1c ≤6.5% (Yes/No) | Week 104/Premature treatment discontinuation | Participants who achieved HbA1c ≤6.5% (yes/no) is presented. |
| Secondary | Participants Who Achieve HbA1c ≤7.0% Without Weight Gain | Week 104/Premature treatment discontinuation | Participants who achieved HbA1c ≤7.0% without weight gain (yes/no) is presented. |
| Secondary | Participants Who Achieve HbA1c ≤7.0% Without Treatment Emergent Severe Hypoglycaemic Episodes or BG Confirmed Symptomatic Hypoglycaemic Episodes | Week 104/Premature treatment discontinuation | Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value \<3.1 millimoles per liter (mmol/L) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than the day after the last day on trial product. Participants who achieved HbA1c ≤7.0% without treatment emergent severe hypoglycaemic episodes or BG confirmed symptomatic hypoglycaemic episodes (yes/no) is presented. |
| Secondary | Participants Who Achieve HbA1c ≤7.0% Without Weight Gain and no Treatment Emergent Severe Hypoglycaemic Episodes or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes | Week 104/Premature treatment discontinuation | Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than the day after the last day on trial product. Participants who achieved HbA1c ≤7.0% without weight gain and no treatment emergent severe hypoglycaemic episodes or BG confirmed symptomatic hypoglycaemic episodes (yes/no) is presented. |
| Secondary | Change in Fasting Plasma Glucose (FPG) | Week 0, week 104/premature treatment discontinuation | Change from baseline (week 0) in FPG at week 104 or at premature treatment discontinuation is presented. |
| Secondary | Change in Body Weight | Week 0, week 104/premature treatment discontinuation | Change from baseline (week 0) in body weight at week 104 or at premature treatment discontinuation is presented. |
| Secondary | Change in Body Mass Index (BMI) | Week 0, week 104/premature treatment discontinuation | Change from baseline (week 0) in BMI at week 104 or at premature treatment discontinuation is presented. |
| Secondary | Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Week 0, week 104/premature treatment discontinuation | Change from baseline (week 0) in systolic and diastolic blood pressure at week 104 or at premature treatment discontinuation is presented. |
| Secondary | Number of Severe Hypoglycaemic Episodes | Weeks 0-104 | Severe hypoglycaemic episodes were defined as episodes that required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Number of severe hypoglycaemic episodes that occured during weeks 0-104 are presented. |
| Secondary | Number of Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | Weeks 0-104 | Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. Number of severe or BG confirmed symptomatic hypoglycaemic episodes that occured during weeks 0-104 are presented. |
| Secondary | Number of Documented Symptomatic Hypoglycaemic Episodes (ADA) | Weeks 0-104 | Documented symptomatic hypoglycaemic were defined as episodes with typical symptoms of hypoglycaemia accompanied by measure plasma glucose concentration \<= 3.9 mmol/L. Number of documented symptomatic hypoglycaemic episodes that occured during the weeks 0-104 are presented. |
| Secondary | Number of Serious Adverse Events (SAEs) | Weeks 0-105 | A serious adverse event (SAE) was defined as any event that resulted in any of the following: death, life-threatening experience, in-patient hospitalisation or prolongation of existing hospitalisation, persistent or significant disability or incapacity, congenital anomaly or birth defect or suspicion of transmission of infectious agents via the trial product. An SAE was considered as treatment emergent if it had an onset or increase in severity on or after the time of first trial product administration and no later than 7 days after the time of last trial product administration. Number of treatment emergent serious adverse events are presented. |
| Secondary | Number of AEs Leading to Permanent Discontinuation of Trial Product | Weeks 0-105 | An adverse event (AE) was any untoward medical occurrence in a participant who administered a product, and which did not necessarily had a causal relationship with this treatment. An AE was considered as treatment emergent if it had an onset or increase in severity on or after the time of first trial product administration and no later than 7 days after the time of last trial product administration. Number of treatment emergent AEs that led to permanent discontinuation of trial product are presented. |
| Secondary | Change in Lipids: HDL Cholesterol, LDL-cholesterol, Total Cholesterol, Triglycerides | Week 0, week 104/premature treatment discontinuation | Change from baseline (week 0) in high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, total cholesterol (TC) and triglycerides (TG) at week 104 or at premature treatment discontinuation is presented. |
| Secondary | Change in Biochemistry- Alanine Aminotransferase (ALAT), Amylase, Aspartate Aminotransferase (ASAT), Lipase | Week 0, week 104/premature treatment discontinuation | Change from baseline (week 0) in alanine aminotransferase (ALAT), amylase, aspartate aminotransferase (ASAT) and lipase at week 104 or at premature treatment discontinuation is presented. |
| Secondary | Change in Biochemistry- Creatinine, Total Bilirubin | Week 0, week 104/premature treatment discontinuation | Change from baseline (week 0) in creatinine and total bilirubin (TB) at week 104 or at premature treatment discontinuation is presented. |
| Secondary | Change in Biochemistry- Estimated Glomerular Filtration Rate (eGFR) Serum | Week 0, week 104/premature treatment discontinuation | The estimated GFR was derived from serum creatinine using the MDRD (Modification of diet in renal disease) formula. eGFR was measured as milliliter per min per specific surface area (mL/min/SSA). |
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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