The Safety and Efficacy of MK-1293 Versus Lantus™ in Participants With Type 2 Diabetes Mellitus (MK-1293-006)

August 8, 2018 updated by: Merck Sharp & Dohme LLC

A Phase III Clinical Trial to Study the Safety and Efficacy of MK-1293 Compared to Lantus™ in Subjects With Type 2 Diabetes Mellitus

This 24-week study is a safety and efficacy comparison of MK-1293 and Lantus™ in participants with type 2 diabetes mellitus (T2DM). The primary hypothesis is that after 24 weeks, the mean change in hemoglobin A1c (A1C) from baseline is non-inferior (with margin of 0.4%) in participants treated with MK-1293 compared with that in participants treated with Lantus™.

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.
531

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 3

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Type 2 Diabetes Mellitus (T2DM) as defined by the American Diabetes Association (ADA) or the European Association for the Study of Diabetes (EASD)
  • hemoglobin A1C of ≤11.0% and requires insulin for glycemic control
  • Body mass index (BMI) <45 kg/m^2

Exclusion Criteria:

  • History of type 1 diabetes mellitus or a history of ketoacidosis, or has type 1 diabetes confirmed with a C-peptide <0.7 ng/mL (0.23 nmol/L)
  • One or more severe hypoglycemic episodes associated with hypoglycemic seizures, comas or unconsciousness within the past 6 months
  • History of intolerance or hypersensitivity to Lantus™ or contraindication to Lantus™ or one of its excipients based on the label of the country of the investigational site
  • On a weight loss program within the last 8 weeks
  • Received injectable incretin-based therapy (e.g., Victoza™, Byetta™) within the prior 8 weeks
  • Bariatric surgery within 12 months prior to signing the informed consent
  • Likely to require treatment for ≥2 consecutive weeks or repeated courses of corticosteroids
  • Undergone a surgical procedure within 4 weeks prior to signing informed consent or has planned major surgery during the study
  • New or worsening signs or symptoms of coronary heart disease or congestive heart failure within the last 3 months
  • Presence of any of the following during the last 3 months: acute coronary syndrome, coronary artery intervention, and/or stroke or transient ischemic neurological disorder
  • Severe peripheral vascular disease
  • Systolic blood pressure ≥ 160 mm Hg or a diastolic ≥95 mm Hg and blood pressure is not considered likely to be under these limits with an adjustment in antihypertensive medication
  • Chronic myopathy or a progressive neurological or neuromuscular disorder
  • Active nephropathy
  • History of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease
  • Human immunodeficiency virus (HIV)
  • Clinically important hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
  • History of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
  • History of melanoma, leukemia, lymphoma, or renal cell carcinoma
  • Hyperthyroidism
  • On a stable dose of thyroid hormone replacement therapy for <6 weeks
  • Uses recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence
  • Pregnant or breast-feeding, or is expecting to conceive or donate eggs during the study, including 14 days following the last dose of study drug
  • Donated blood products or has had phlebotomy of >300 mL within 8 weeks of signing informed consent, or intends to donate blood products within the projected duration of the study
  • Poor mental function or any other reason to expect that the participant may have difficulty in complying with the requirements of the study
  • Clinically significant ECG abnormality which exposes the participant to risk by enrolling in the study
  • Positive urine pregnancy test
  • Participant is a night shift worker which causes difficulty complying with the overnight fast requirement and has potential for confounding the 7-point SMBG analysis
  • Participant, as assessed by the investigator, is not appropriate for or does not agree to target a fasting glucose of 70-100 mg/dL [3.9 -5.6 mmol/L]
  • Has used a formulation of glargine insulin other than Lantus™

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 Assignment
  • Masking: None (Open Label)

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.
Experimental: MK-1293
MK-1293 administered subcutaneously once daily in the evening.
Drug: MK-1293
MK-1293 (insulin glargine) 100 units/mL administered subcutaneously once daily for 24 weeks. Participants not taking insulin at study entry will initiate MK-1293 at 10 units daily. Participants taking insulin will initiate MK-1293 at an appropriate dose based on prior insulin dosing. After initiation, the dose will be titrated to the suggested target for fasting finger stick glucose. MK-1293 dosing once daily at times other than bedtime will be permitted for participants with a previously established dosing time.
Drug: Prandial insulin
Participants taking prandial insulin will continue their current prandial insulin regimen during the insulin glargine titration. After the insulin glargine titration phase, the prandial insulin may be adjusted if the investigator determines it to be necessary for glucose control.
Active Comparator: Lantus™
Lantus™ administered subcutaneously once daily in the evening.
Drug: Prandial insulin
Participants taking prandial insulin will continue their current prandial insulin regimen during the insulin glargine titration. After the insulin glargine titration phase, the prandial insulin may be adjusted if the investigator determines it to be necessary for glucose control.
Drug: Lantus™
Lantus™ (insulin glargine [rDNA origin]) 100 units/mL administered subcutaneously once daily for 24 weeks. Participants not taking insulin at study entry will initiate Lantus™ at 10 units daily. Participants taking insulin will initiate Lantus™ at an appropriate dose based on prior insulin dosing. After initiation, the dose will be titrated to the suggested target for fasting finger stick glucose. Lantus™ dosing once daily at times other than bedtime will be permitted for participants with a previously established dosing time.
Other Names:
  • Insulin glargine [rDNA origin]

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 Participant Hemoglobin A1C Level at Week 24
Time Frame: Baseline and Week 24
A1C is measured as a percent. A1C is the key glycemic parameter which correlates with reduction of risk of diabetic complications.
Baseline and Week 24
Percentage of Participants With Confirmed Anti-Insulin Antibodies (AIA) up to Week 24
Time Frame: Up to 24 weeks
Percentage of participants is a cumulative percentage of participants with any confirmed AIA (including baseline) up to Week 24.
Up to 24 weeks

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
Change From Baseline in Participant Body Weight at Week 24
Time Frame: Baseline and Week 24
Change from baseline in participant body weight at Week 24.
Baseline and Week 24
Percentage of Participants Experiencing an Adverse Event (AE) of Hypoglycemia Up to Week 24
Time Frame: Up to 24 weeks
Symptomatic events assessed as likely to be hypoglycemia were to be reported by investigators as adverse events of hypoglycemia; a concurrent glucose measurement was not required. Asymptomatic events with confirmed glucose levels </= 70mg/dL (</= 3.9mmol/L) could also be reported as adverse events at the discretion of the investigator.
Up to 24 weeks
Percentage of Participants Experiencing an AE Over the 24-week Treatment Period
Time Frame: Up to 24 weeks
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the investigational product, is also an AE.
Up to 24 weeks
Daily Basal Insulin Dose (Units) at Week 24
Time Frame: Week 24
The daily basal insulin dose (measured in units) for any given visit is defined as the average dose from the three most recent days preceding the visit date.
Week 24
Daily Basal Insulin Dose Per Body Weight (Units/kg) at Week 24
Time Frame: Week 24
Basal insulin dose per body weight was calculated as total insulin dose (units) per day divided by body weight in kilograms (kg).
Week 24
Change From Baseline in Participant Fasting Plasma Glucose (FPG) at Week 24
Time Frame: Baseline and Week 24
Participants fasted (no food or drink except water and non-antihyperglycemic non-study medications as prescribed) for at least 8 hours prior to all study visits.
Baseline and Week 24
Change From Baseline in Participant 7-Point Average of Self-Monitored Blood Glucose (SMBG) at Week 24
Time Frame: Baseline and Week 24
7-Point Average of SMBG was defined as the mean of blood glucose measurements taken at the following 7 times: before morning meal, after morning meal, before midday meal, after midday meal, before evening meal, after evening meal or at bedtime, and between 2 AM and 4 AM.
Baseline and Week 24
Percentage of Participants With Hemoglobin A1C <7% at Week 24
Time Frame: Week 24
Percentage of participants with A1C <7.0% (53 mmol/mol) at Week 24.
Week 24
Percentage of Participants With Hemoglobin A1C <6.5% at Week 24
Time Frame: Week 24
Percentage of participants with A1C <6.5% (48 mmol/mol) at Week 24.
Week 24

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 Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

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.
February 11, 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.
March 11, 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.
March 11, 2015

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).
February 7, 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.
February 7, 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.
February 11, 2014

Study Record Updates

Last Update Posted (Actual)

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.
September 6, 2018

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.
August 8, 2018

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.
August 1, 2018

More Information

Terms related to this study

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.
  • 1293-006
  • 2012-003478-19 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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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