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

NCT02252965 | Completed Phase 4 Results DMC

• 1 other identifier: 200084-513
• Study Type: interventional
• Target: 532
• Locations: 1 country
• Sites: 1

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 (%).

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2; Metformin XR; Metformin IR

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Percentage of Subjects With Pre-specified Gastrointestinal Adverse Events During Treatment Period

  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

  Baseline, Week 8 and 16

• Percentage of Subjects With Hypoglycemia

  Baseline up to Week 16

• Percentage of Subjects With Marked Hyperglycemia

  Baseline up to Week 16

Study Arms (2)

Metformin IR

ACTIVE COMPARATOR

Drug: Metformin IR

Metformin XR

EXPERIMENTAL

Drug: Metformin XR

Interventions

Metformin IR DRUG

Subjects will receive Metformin Immediate Release (IR) tablets, orally once daily at a dose of 500 milligram (mg) for 1 week, and then dose will increase with increments of 500 mg every week in first 2 weeks to 1500 mg. After that dose will increase up to maximum dose of 2000 mg for the next 2 weeks and will be maintained at 2000 mg until Week 16.

Also known as: Glucophage IR

Metformin IR

Metformin XR DRUG

Subjects will receive Metformin Extended Release (XR) tablets, orally once daily at a dose of 500 mg for 1 week, and then dose will increase with increments of 500 mg every week in first 2 weeks to 1500 mg. After that dose will increase up to maximum dose of 2000 mg for the next 2 weeks and will be maintained at 2000 mg until Week 16.

Also known as: Glucophage XR

Metformin XR

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (\<) 35 kilogram per square meter (kg/m\^2)
• In the opinion of the investigator, subjects are well-motivated, capable and willing to continue the study treatment as required during the whole study period, maintain a study dietary, as required for this protocol, attend scheduled visits and be willing to receive phone calls between visits, avoid pregnancy by using an adequate method of contraception throughout the duration of the study for the female subjects of child bearing potential (and if appropriate male subjects with female partners of childbearing potential)
• Written informed consent given before any trial-related activities are carried out

You may not qualify if:

• Type 1 diabetes
• Previous treatment with insulin or other antidiabetics (including Chinese traditional medicine) for more than 14 days continuously or within 1 month of enrolment
• Any of the protocol-specified cardiovascular conditions within 3 months prior to the screening visit
• Impaired liver function as defined in the protocol
• Serum creatinine values as specified in the protocol
• Known proliferative retinopathy or maculopathy requiring acute treatment, or recurrent major hypoglycemia or hypoglycemic unawareness as judged by the investigator
• Persistent uncontrolled hypertension
• Severe chronic gastrointestinal disease
• Previous history of 1 or more episodes of ketoacidosis or hyperosmolar state/coma
• Currently receiving chronic (\>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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Please contact the Merck KGaA Communication Center

Darmstadt, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck Serono Co., Ltd., Beijing, China

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: September 30, 2014
• Study Start: December 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: April 1, 2016
• Last Updated: January 24, 2017
• Results First Posted: January 24, 2017

Record last verified: 2016-11

Locations

DE (1)