Metformin Extended Release Versus Metformin Immediate Release in Subjects With Type 2 Diabetes (CONSENT)

Diabetes Mellitus, Type 2 Clinical Trial

— CONSENT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02252965
• Other study ID #: 200084-513
• Status: Completed
• Phase: Phase 4
• First received: September 26, 2014
• Last updated: June 30, 2016
• Start date: December 2014
• Est. completion date: April 2016

Study information

• Verified date: June 2016
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeChina: Food and Drug AdministrationChina: Ministry of HealthChina: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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 (%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 532
• Est. completion date: April 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Metformin XR
Metformin XR tablets will be administered orally once daily at a dose of 500 milligram (mg) for 1 week, followed by 1000 mg for 1 week, then 1500 mg for next 2 weeks, and then 2000 mg orally once daily for subsequent 12 weeks.
• Metformin IR
Metformin IR tablets will be administered orally at a dose of 500 mg once daily for 1 week, followed by 500 mg twice daily for 1 week, then 500 mg three times daily for next 2 weeks, and then 2000 mg daily for subsequent 12 weeks.

Locations

Country	Name	City	State
Germany	Please contact the Merck KGaA Communication Center	Darmstadt

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in HbA1c at Week 16		Baseline and Week 16	No
Primary	Percentage of Subjects With Gastrointestinal Adverse Events During Treatment Period		Up to Week 16	Yes
Secondary	Number of Subjects With Pre-specified Gastrointestinal Adverse Events During Treatment Period	Number of subjects with diarrhea, nausea, abdominal pain, bloating, constipation, dyspepsia and flatulence will be reported.	Up to Week 16	Yes
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 4, 8, 12, and 16		Baseline, Weeks 1, 2, 4, 8, 12, and 16	No
Secondary	Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Weeks 8 and 16		Baseline, Weeks 8, and 16	No
Secondary	Number of Subjects With Hypoglycemia		Up to Week 16	Yes
Secondary	Number of Subjects With Marked Hyperglycemia That is FPG >=11.1 Millimole Per Liter (mmol/L)		Up to Week 16	Yes
Secondary	Percentage of Subjects With HbA1c Less Than 7%		Up to Week 16	No
Secondary	Percentage of Subjects who are Totally Intolerant to the study treatment		Up to Week 16	No
Secondary	Percentage of Subjects With HbA1c Less Than 7% and With no Severe Gastrointestinal and Other Adverse Events		Up to Week 16	Yes
Secondary	Percentage of Subjects who are Compliant to Study Treatment		Week 1 up to Week 16	No
Secondary	Number of Subjects With Adverse Events and Serious Adverse Events		Baseline up to Week 18	Yes