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

November 28, 2016 updated by: Merck KGaA, Darmstadt, Germany

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

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 (%).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
532

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Darmstadt, Germany
        • Please contact the Merck KGaA Communication Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Metformin IR
Drug: Metformin IR
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.
Other Names:
  • Glucophage IR
EXPERIMENTAL: Metformin XR
Drug: Metformin XR
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.
Other Names:
  • Glucophage XR

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16
Time Frame: Baseline, Week 16
Baseline, Week 16
Overall Gastrointestinal (GI) Tolerability Assessed as Percentage of Subjects With Gastrointestinal Adverse Events During Treatment Period
Time Frame: Baseline up to Week 16
An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product.
Baseline up to Week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Subjects With Pre-specified Gastrointestinal Adverse Events During Treatment Period
Time Frame: Baseline up to Week 16
An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Number of subjects with pre-specified gastrointestinal adverse events (diarrhea, nausea, abdominal pain, bloating, constipation, dyspepsia and flatulence) were reported.
Baseline up to Week 16
Change From Baseline in Fasting Plasma Glucose (FPG) Level at Week 1, 2, 4, 8, 12 and 16
Time Frame: Baseline, Week 1, 2, 4, 8, 12,16
Baseline, Week 1, 2, 4, 8, 12,16
Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) Level at Weeks 8 and 16
Time Frame: Baseline, Week 8 and 16
The 2-hour Postprandial plasma glucose (PPG) level refers to the plasma glucose concentrations after 2 hours of eating.
Baseline, Week 8 and 16
Percentage of Subjects With Hypoglycemia
Time Frame: Baseline up to Week 16
Hypoglycemia, also called as low blood glucose or low blood sugar, is defined as the blood glucose level of less than normal (that is less than 3.9 millimole per liter [mmol/L]).
Baseline up to Week 16
Percentage of Subjects With Marked Hyperglycemia
Time Frame: Baseline up to Week 16
Marked hyperglycemia was defined as the FPG level of greater than or equal to 11.1 mmol/L.
Baseline up to Week 16
Percentage of Subjects With HbA1c Less Than (<) 7%
Time Frame: Baseline up to Week 16
Baseline up to Week 16
Percentage of Subjects Who Are Totally Intolerant to the Treatment
Time Frame: Baseline up to Week 16
Subjects were considered to be totally intolerant if they experienced a Grade 3 or higher toxicity considered at least possibly related to the treatment.
Baseline up to Week 16
Percentage of Subjects With HbA1c Less Than (<) 7% and With no Severe Gastrointestinal (GI) and Other Adverse Events (AEs)
Time Frame: Baseline up to Week 16
Percentage of subjects with HbA1c <7% and with no severe GI and other AEs were reported. Severe adverse events were based on Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 and were defined as those events which were medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL). Self-care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden.
Baseline up to Week 16
Percentage of Subjects Who Are Compliant to Treatment
Time Frame: Baseline up to Week 16
Compliance was defined as not skipping or forgetting dosing or not delaying the dosing time. Subjects who never missed a dose of medication were considered compliant.
Baseline up to Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck KGaA, Darmstadt, Germany

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Responsible, Merck Serono Co., Ltd., Beijing, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 24, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 200084-513

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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