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Diabetes Mellitus, Type 2Phase 4CONSENTNCT02252965

Metformin Extended Release Versus Metformin Immediate Release in Subjects With Type 2 Diabetes

A Phase 4 study testing Metformin IR and Metformin XR in people with Diabetes Mellitus, Type 2, run by Merck KGaA, Darmstadt, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Metformin IR and Metformin XR
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
532 participants
Where
1 siteGermany
Study dates
Dec 2014to Apr 2016
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Please contact the Merck KGaA Communication Center

    Darmstadt

Other trials in Germany

About this study

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

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 (%).

Being tested
Metformin IR, Metformin XR
Keywords
Diabetes Mellitus, Type 2, Metformin XR, Metformin IR
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Metformin IRDrug

    Also called Glucophage 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.

  • Metformin XRDrug

    Also called Glucophage 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.

Study groups in NCT02252965
Study groupRoleWhat they receive
Metformin IRActive comparatorNot described
Receives: Drug: Metformin IR
Metformin XRExperimentalNot described
Receives: Drug: Metformin XR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16

    Measured: Baseline, Week 16

  2. Overall Gastrointestinal (GI) Tolerability Assessed as Percentage of Subjects With Gastrointestinal Adverse Events During Treatment Period

    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.

    Measured: Baseline up to Week 16

Secondary outcomes (9)

  1. Percentage of Subjects With Pre-specified Gastrointestinal Adverse Events During Treatment Period

    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.

    Measured: Baseline up to Week 16

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

    Measured: Baseline, Week 1, 2, 4, 8, 12,16

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

    The 2-hour Postprandial plasma glucose (PPG) level refers to the plasma glucose concentrations after 2 hours of eating.

    Measured: Baseline, Week 8 and 16

  4. Percentage of Subjects With Hypoglycemia

    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]).

    Measured: Baseline up to Week 16

  5. Percentage of Subjects With Marked Hyperglycemia

    Marked hyperglycemia was defined as the FPG level of greater than or equal to 11.1 mmol/L.

    Measured: Baseline up to Week 16

  6. Percentage of Subjects With HbA1c Less Than (<) 7%

    Measured: Baseline up to Week 16

  7. Percentage of Subjects Who Are Totally Intolerant to the Treatment

    Subjects were considered to be totally intolerant if they experienced a Grade 3 or higher toxicity considered at least possibly related to the treatment.

    Measured: Baseline up to Week 16

  8. Percentage of Subjects With HbA1c Less Than (<) 7% and With no Severe Gastrointestinal (GI) and Other Adverse Events (AEs)

    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.

    Measured: Baseline up to Week 16

  9. Percentage of Subjects Who Are Compliant to Treatment

    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.

    Measured: Baseline up to Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionNov 2015
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
532 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02252965
Sponsor's protocol ID
200084-513
Acronym
CONSENT
Status last verified
Nov 2016
First submitted
26 Sep 2014
Last updated
24 Jan 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Metformin IR and Metformin XR in people with Diabetes Mellitus, Type 2, run by Merck KGaA, Darmstadt, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16 (time frame: Baseline, Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02252965.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2017.

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