Metformin Extended Release Versus Metformin Immediate Release in Subjects With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Metformin IR; Metformin XR
Intervention description: 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.; 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.
Intervention MeSH terms: Metformin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 532.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus, Type 2; Metformin XR; Metformin IR

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