Metformin Extended Release Versus Metformin Immediate Release in Subjects With Type 2 Diabetes

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Metformin XR; Drug: Metformin IR

• Registration Number: NCT02252965
• Lead Sponsor: Merck KGaA, Darmstadt, Germany

Brief Summary

This is a Phase 4, prospective, open label, randomized, parallel controlled multicenter trial in which metformin extended release (XR) will be compared with metformin immediate release (IR) for the gastrointestinal tolerability and efficacy in the newly diagnosed subjects with Type 2 diabetes who have glycosylated hemoglobin (HbA1c) value between 7.0 to 10.0 percent (%).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-26
• Study First Submitted QC: 2014-09-26
• Study First Posted: 2014-09-30
• Study Start: 2014-12
• Primary Completion: 2015-11
• Study Completion: 2016-04
• Status Verified: 2016-11
• Results First Submitted: 2016-11-28
• Results First Submitted QC: 2016-11-28
• Last Update Submitted: 2016-11-28
• Results First Posted: 2017-01-24
• Last Update Posted: 2017-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 532

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin XR	Metformin XR	-
Metformin IR	Metformin IR	-

Primary Outcome Measures

Name	Time	Method
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	Baseline up to Week 16	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects With Marked Hyperglycemia	Baseline up to Week 16	Marked hyperglycemia was defined as the FPG level of greater than or equal to 11.1 mmol/L.
Percentage of Subjects With HbA1c Less Than (<) 7% and With no Severe Gastrointestinal (GI) and Other Adverse Events (AEs)	Baseline up to Week 16	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.
Percentage of Subjects With Pre-specified Gastrointestinal Adverse Events During Treatment Period	Baseline up to Week 16	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.
Percentage of Subjects With HbA1c Less Than (<) 7%	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
Percentage of Subjects Who Are Totally Intolerant to the Treatment	Baseline up to Week 16	Subjects were considered to be totally intolerant if they experienced a Grade 3 or higher toxicity considered at least possibly related to the treatment.
Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) Level at Weeks 8 and 16	Baseline, Week 8 and 16	The 2-hour Postprandial plasma glucose (PPG) level refers to the plasma glucose concentrations after 2 hours of eating.
Percentage of Subjects With Hypoglycemia	Baseline up to Week 16	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 \[mmol/L\]).
Percentage of Subjects Who Are Compliant to Treatment	Baseline up to Week 16	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.

Trial Locations

Locations (1)

Please contact the Merck KGaA Communication Center; 🇩🇪 Darmstadt, Germany