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

NCT02059187 | Completed Phase 3 Results

• 2 other identifiers: 1293-0062012-003478-19
• Study Type: interventional
• Target: 531
• Locations: 0 countries
• Sites: N/A

Brief 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 with that in participants treated with Lantus™.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and Week 24

• 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.

  Up to 24 weeks

Secondary Outcomes (9)

• 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

  Up to 24 weeks

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

  Up to 24 weeks

• Daily Basal Insulin Dose (Units) at Week 24

  Week 24

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

  Week 24

Study Arms (2)

MK-1293

EXPERIMENTAL

MK-1293 administered subcutaneously once daily in the evening.

Drug: MK-1293; Drug: Prandial insulin

Lantus™

ACTIVE COMPARATOR

Lantus™ administered subcutaneously once daily in the evening.

Drug: Lantus™; Drug: Prandial insulin

Interventions

MK-1293 DRUG

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.

MK-1293

Lantus™ DRUG

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.

Also known as: Insulin glargine [rDNA origin]

Lantus™

Prandial insulin DRUG

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.

Lantus™; MK-1293

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 29761615 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

MK-1293; Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2014
• First Posted: February 11, 2014
• Study Start: February 11, 2014
• Primary Completion: March 11, 2015
• Study Completion: March 11, 2015
• Last Updated: September 6, 2018
• Results First Posted: March 8, 2017

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share