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Clinical Trial Details

Trial ID: L2392
Source ID: NCT02252965
Associated Drug: Metformin Ir
Title: Metformin Extended Release Versus Metformin Immediate Release in Subjects With Type 2 Diabetes
Acronym: CONSENT
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02252965/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Metformin IR|DRUG: Metformin XR
Outcome Measures: Primary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16, Baseline, Week 16|Overall Gastrointestinal (GI) Tolerability Assessed as Percentage of Subjects With Gastrointestinal Adverse Events During Treatment Period, An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product., Baseline up to Week 16 | Secondary: Percentage of Subjects With Pre-specified Gastrointestinal Adverse Events During Treatment Period, An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Number of subjects with pre-specified gastrointestinal adverse events (diarrhea, nausea, abdominal pain, bloating, constipation, dyspepsia and flatulence) were reported., Baseline up to Week 16|Change From Baseline in Fasting Plasma Glucose (FPG) Level at Week 1, 2, 4, 8, 12 and 16, Baseline, Week 1, 2, 4, 8, 12,16|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) Level at Weeks 8 and 16, The 2-hour Postprandial plasma glucose (PPG) level refers to the plasma glucose concentrations after 2 hours of eating., Baseline, Week 8 and 16|Percentage of Subjects With Hypoglycemia, Hypoglycemia, also called as low blood glucose or low blood sugar, is defined as the blood glucose level of less than normal (that is less than 3.9 millimole per liter \[mmol/L\])., Baseline up to Week 16|Percentage of Subjects With Marked Hyperglycemia, Marked hyperglycemia was defined as the FPG level of greater than or equal to 11.1 mmol/L., Baseline up to Week 16|Percentage of Subjects With HbA1c Less Than (<) 7%, Baseline up to Week 16|Percentage of Subjects Who Are Totally Intolerant to the Treatment, Subjects were considered to be totally intolerant if they experienced a Grade 3 or higher toxicity considered at least possibly related to the treatment., Baseline up to Week 16|Percentage of Subjects With HbA1c Less Than (<) 7% and With no Severe Gastrointestinal (GI) and Other Adverse Events (AEs), Percentage of subjects with HbA1c \<7% and with no severe GI and other AEs were reported. Severe adverse events were based on Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 and were defined as those events which were medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL). Self-care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden., Baseline up to Week 16|Percentage of Subjects Who Are Compliant to Treatment, Compliance was defined as not skipping or forgetting dosing or not delaying the dosing time. Subjects who never missed a dose of medication were considered compliant., Baseline up to Week 16
Sponsor/Collaborators: Sponsor: Merck KGaA, Darmstadt, Germany
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 532
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-12
Completion Date: 2016-04
Results First Posted: 2017-01-24
Last Update Posted: 2017-01-24
Locations: Please contact the Merck KGaA Communication Center, Darmstadt, Germany
URL: https://clinicaltrials.gov/show/NCT02252965