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Type 2 Diabetes MellitusPhase 3NCT02059187

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

A Phase 3 study testing MK-1293, Lantus™ and Prandial insulin in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.

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 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
MK-1293, Lantus™ and Prandial insulin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
531 participants
Where
No sites listed yet
Study dates
11 Feb 2014to 11 Mar 2015
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 30Show fewer
  • 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™

About this study

Official title: 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™.

Being tested
MK-1293, Lantus™, Prandial insulin
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.

  • MK-1293Drug

    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.

  • Lantus™Drug

    Also called Insulin glargine [rDNA origin]

    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.

  • Prandial insulinDrug

    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.

Study groups in NCT02059187
Study groupRoleWhat they receive
MK-1293ExperimentalMK-1293 administered subcutaneously once daily in the evening.
Receives: Drug: MK-1293; Drug: Prandial insulin
Lantus™Active comparatorLantus™ administered subcutaneously once daily in the evening.
Receives: Drug: Lantus™; Drug: Prandial insulin

What is being measured

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

  1. Change From Baseline in Participant Hemoglobin A1C Level at Week 24

    A1C is measured as a percent. A1C is the key glycemic parameter which correlates with reduction of risk of diabetic complications.

    Measured: Baseline and Week 24

  2. Percentage of Participants With Confirmed Anti-Insulin Antibodies (AIA) up to Week 24

    Percentage of participants is a cumulative percentage of participants with any confirmed AIA (including baseline) up to Week 24.

    Measured: Up to 24 weeks

Secondary outcomes (9)

  1. Change From Baseline in Participant Body Weight at Week 24

    Change from baseline in participant body weight at Week 24.

    Measured: Baseline and Week 24

  2. Percentage of Participants Experiencing an Adverse Event (AE) of Hypoglycemia Up to Week 24

    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.

    Measured: Up to 24 weeks

  3. Percentage of Participants Experiencing an AE Over the 24-week Treatment Period

    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.

    Measured: Up to 24 weeks

  4. Daily Basal Insulin Dose (Units) at 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.

    Measured: Week 24

  5. Daily Basal Insulin Dose Per Body Weight (Units/kg) at Week 24

    Basal insulin dose per body weight was calculated as total insulin dose (units) per day divided by body weight in kilograms (kg).

    Measured: Week 24

  6. Change From Baseline in Participant Fasting Plasma Glucose (FPG) at 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.

    Measured: Baseline and Week 24

  7. Change From Baseline in Participant 7-Point Average of Self-Monitored Blood Glucose (SMBG) at 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.

    Measured: Baseline and Week 24

  8. Percentage of Participants With Hemoglobin A1C <7% at Week 24

    Percentage of participants with A1C <7.0% (53 mmol/mol) at Week 24.

    Measured: Week 24

  9. Percentage of Participants With Hemoglobin A1C <6.5% at Week 24

    Percentage of participants with A1C <6.5% (48 mmol/mol) at Week 24.

    Measured: Week 24

Timeline

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

  1. First posted11 Feb 2014 (estimated)
  2. Study start11 Feb 2014
  3. Primary completion11 Mar 2015
  4. Study completion11 Mar 2015

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
531 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02059187
Sponsor's protocol ID
1293-006
Other IDs
2012-003478-19
Status last verified
Aug 2018
First submitted
7 Feb 2014
Last updated
6 Sep 2018
Data monitoring committee
No
Individual data sharing
Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Hollander PA, Carofano WL, Lam RLH, Golm GT, Eldor R, Crutchlow MF, Marcos MC, Rendell MS, Home PD, Gallwitz B, Rosenstock J. Efficacy and safety of MK-1293 insulin glargine compared with originator insulin glargine (Lantus) in type 2 diabetes: A randomized, open-label clinical trial. Diabetes Obes Metab. 2018 Sep;20(9):2229-2237. doi: 10.1111/dom.13363. Epub 2018 Jun 10.

    PubMed 29761615

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MK-1293, Lantus™ and Prandial insulin in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.

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 3 inclusion and 30 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 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 8 Mar 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 Participant Hemoglobin A1C Level at Week 24 (time frame: Baseline and Week 24). 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 NCT02059187, which also lists 1 linked publication.

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 6 Sep 2018.

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