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 16Percentage of Subjects With Gastrointestinal Adverse Events During Treatment Period
Secondary outcome: Number of Subjects With Pre-specified Gastrointestinal Adverse Events During Treatment PeriodChange 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
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