Clinical trial NCT02252965: Metformin Extended Release Versus Metformin Immediate Release in Subjects With Type 2 Diabetes
Official title: CONSENT - Comparison of metfOrmin XR to IR as moNotherapy in the Newly diagnoSed Type 2 diabEtes Patients for the gastroiNtestinal Tolerability and Efficacy: a Randomized, Parallel Control, Open-label and Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
Metformin XR
Metformin IR
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2014-09-30
Enrollment: 532
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (%).


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 (\<) 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

Exclusion criteria:

* 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
* Any contraindications to Metformin according to local package insert

Primary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16
timeFrame: Baseline, Week 16
measure: Overall Gastrointestinal (GI) Tolerability Assessed as Percentage of Subjects With Gastrointestinal Adverse Events During Treatment Period
timeFrame: Baseline up to Week 16
Secondary outcomes:
measure: Percentage of Subjects With Pre-specified Gastrointestinal Adverse Events During Treatment Period
timeFrame: Baseline up to Week 16
measure: Change From Baseline in Fasting Plasma Glucose (FPG) Level at Week 1, 2, 4, 8, 12 and 16
timeFrame: Baseline, Week 1, 2, 4, 8, 12,16
measure: Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) Level at Weeks 8 and 16
timeFrame: Baseline, Week 8 and 16
measure: Percentage of Subjects With Hypoglycemia
timeFrame: Baseline up to Week 16
measure: Percentage of Subjects With Marked Hyperglycemia
timeFrame: Baseline up to Week 16
measure: Percentage of Subjects With HbA1c Less Than (<) 7%
timeFrame: Baseline up to Week 16
measure: Percentage of Subjects Who Are Totally Intolerant to the Treatment
timeFrame: Baseline up to Week 16
measure: Percentage of Subjects With HbA1c Less Than (<) 7% and With no Severe Gastrointestinal (GI) and Other Adverse Events (AEs)
timeFrame: Baseline up to Week 16
measure: Percentage of Subjects Who Are Compliant to Treatment
timeFrame: Baseline up to Week 16
Other outcomes:
Locations:
city: Darmstadt
country: Germany
facility: Please contact the Merck KGaA Communication Center
Study officials:
affiliation: Merck Serono Co., Ltd., Beijing, China
name: Medical Responsible
role: STUDY_DIRECTOR
References: