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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT02059187
First received: February 7, 2014
Last updated: October 24, 2014
Last verified: October 2014
  Purpose

This 24-week study is a safety and efficacy comparison of MK-1293 and Lantus™ participants with type 2 diabetes mellitus (T2DM).


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: MK-1293
Drug: Lantus™
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants With Confrmed Anti-Insulin Antibodies up to Week 24 [ Time Frame: Up to Week 24 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Participant Hemoglobin A1C Level at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline in Participant Body Weight at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Number of Participants Experiencing Hypoglycemia Up to Week 24 [ Time Frame: Up to Week 24 ] [ Designated as safety issue: Yes ]
  • Number of Participants Experiencing an Adverse Event (AE) Up to Week 24 [ Time Frame: Up to Week 24 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Participant Daily Insulin Dose (Units) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Change From Baseline in Participant Insulin Dose Per Body Weight (Units/kg) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Change From Baseline in Participant Fasting Plasma Glucose (FPG) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Change From Baseline in Participant 7-Point Self-Monitored Blood Glucose (SMBG) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Proportion of Participants With Hemoglobin A1C <7% at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Proportion of Participants With Hemoglobin A1C <6.5% at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: February 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-1293
MK-1293 administered subcutaneously once daily.
Drug: MK-1293
MK-1293 administered subcutaneously. Dosing will be initiated based on the participant's prior insulin dosing, and may be modified at the investigator's discretion to meet the individual participant's needs.
Active Comparator: Lantus™
Lantus™ administered subcutaneously once daily.
Drug: Lantus™
Lantus™ administered subcutaneously. Dosing will be initiated based on the participant's prior insulin dosing, and may be modified at the investigator's discretion to meet the individual participant's needs.
Other Name: Insulin glargine [rDNA origin]

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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™
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02059187     History of Changes
Other Study ID Numbers: 1293-006, 2012-003478-19
Study First Received: February 7, 2014
Last Updated: October 24, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glargine
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014