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

Information source: Merck KGaA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: Metformin XR (Drug); Metformin IR (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Merck KGaA

Official(s) and/or principal investigator(s):
Medical Responsible, Study Director, Affiliation: Merck Serono. Co., Ltd, Beijing, China

Overall contact:
Merck KGaA Communication Center, Phone: +49 6151 72 5200, Email: service@merckgroup.com

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 (%).

Clinical Details

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

Primary outcome:

Change From Baseline in HbA1c at Week 16

Percentage of Subjects With Gastrointestinal Adverse Events During Treatment Period

Secondary outcome:

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

Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 4, 8, 12, and 16

Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Weeks 8 and 16

Number of Subjects With Hypoglycemia

Number of Subjects With Marked Hyperglycemia That is FPG >=11.1 Millimole Per Liter (mmol/L)

Percentage of Subjects With HbA1c Less Than 7%

Percentage of Subjects who are Totally Intolerant to the study treatment

Percentage of Subjects With HbA1c Less Than 7% and With no Severe Gastrointestinal and Other Adverse Events

Percentage of Subjects who are Compliant to Study Treatment

Number of Subjects With Adverse Events and Serious Adverse Events

Eligibility

Minimum age: 18 Years. Maximum age: 79 Years. Gender(s): Both.

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

Locations and Contacts

Merck KGaA Communication Center, Phone: +49 6151 72 5200, Email: service@merckgroup.com

Please contact the Merck KGaA Communication Center, Darmstadt, Germany; Recruiting
Phone: +49 6151 72 5200, Email: service@merckgroup.com
Additional Information

Starting date: December 2014
Last updated: April 29, 2015

Page last updated: August 23, 2015

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