Phase 4
N=532
Metformin Extended Release Versus Metformin Immediate Release in Subjects With Type 2 Diabetes
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT02252965 ↗Enrolled (actual)
532
Serious AEs
1.5%
Results posted
Jan 2017
Primary outcome: Primary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16 — -1.61; -1.58 Percentage of HbA1c
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Metformin IR (Drug); Metformin XR (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16 |
-1.61; -1.58 | — |
| PRIMARY Overall Gastrointestinal (GI) Tolerability Assessed as Percentage of Subjects With Gastrointestinal Adverse Events During Treatment Period |
23.8; 22.3 | 0.674 |
| SECONDARY Percentage of Subjects With Pre-specified Gastrointestinal Adverse Events During Treatment Period |
16.5; 12.5; 6.1; 6.4; 6.1; 4.5 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) Level at Week 1, 2, 4, 8, 12 and 16 |
8.464; 8.690; -0.647; -0.736; -1.324; -1.267 | — |
| SECONDARY Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) Level at Weeks 8 and 16 |
14.604; 14.764; -3.608; -3.264; -3.642; -3.693 | — |
| SECONDARY Percentage of Subjects With Hypoglycemia |
1.1; 3.0 | — |
| SECONDARY Percentage of Subjects With Marked Hyperglycemia |
0.7; 2.3 | — |
| SECONDARY Percentage of Subjects With HbA1c Less Than (<) 7% |
68.5; 69.8 | — |
| SECONDARY Percentage of Subjects Who Are Totally Intolerant to the Treatment |
7.3; 5.7 | — |
| SECONDARY Percentage of Subjects With HbA1c Less Than (<) 7% and With no Severe Gastrointestinal (GI) and Other Adverse Events (AEs) |
68.2; 69.8 | — |
| SECONDARY Percentage of Subjects Who Are Compliant to Treatment |
99.2; 99.2 | — |
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 (%).
Eligibility Criteria
Inclusion criteria
- Diagnosis of Type 2 diabetes mellitus before the screening visit based on the World Health Organization (WHO) diagnostic and classification criteria
- HbA1c value of 7.0-10.0%, inclusive
- Age ranging from 18 to 79 years, inclusive
- Treatment-naive for oral antidiabetic agents (that is, had not received antidiabetic medication previously, or had received antidiabetic medication for at least 14 days and not within 1 month of enrolment)
- Male, or non-pregnant, non-breastfeeding females
- Body mass index (BMI) greater than or equal to (>=) 18.5 and less than ( 14 days) systemic glucocorticoid therapy (excluding topical, intraocular, inhaled or intranasal preparations) or have received such therapy within 4 weeks of the screening visit
- Current use of beta-blockers, thiazide diuretic, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, nifedipine and isoniazid and cannot be replaced by any other treatment
- Have any hematologic condition that may interfere with HbA1c measurement (for example, hemolytic anemia, sickle-cell disease)
- Have any other condition (such as, known drug or alcohol abuse or a psychiatric disorder) that may prevent the subject from following and completing the protocol
- Known hypersensitivity to Metformin Hydrochloride
- Currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Any contraindications to Metformin according to local package insert
Data sourced from ClinicalTrials.gov (NCT02252965). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.