A Study of the Safety and Efficacy of MK-1293 Compared to Lantus™ in Participants With Type 1 Diabetes Mellitus (T1DM) (MK-1293-003)

NCT02059161 | Completed Phase 3 Results

• 2 other identifiers: 1293-0032011-003971-12
• Study Type: interventional
• Target: 508
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the safety and efficacy of MK-1293 to Lantus™ in participants with T1DM. The primary hypothesis is that after 24 weeks, the mean change in hemoglobin A1c (A1C) from baseline is non-inferior in participants treated with MK-1293 compared with participants treated with Lantus™.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (5)

• Primary: Change From Baseline in Hemoglobin A1c (A1C) at Week 24

  A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 24 A1C minus the Week 0 A1C.

  Baseline and Week 24

• Percentage of Participants With Any Confirmed Positive Anti-insulin Antibody (AIA) at Any Time Up Through Week 24

  Percentage of participants with confirmed positive AIA at any time up through Week 24 including baseline.

  Up to Week 24

• Percentage of Participants With Negative AIA at Baseline Who Develop Confirmed Positive AIA at Any Time Up Through Week 24

  Percentage of participants who became positive to AIA at or before Week 24, among participants who were AIA negative at baseline.

  Up to Week 24

• Change From Baseline in AIA Titer After 24 Weeks of Treatment

  This immunogenicity analysis will assess the effect of treatment with MK-1293 compared with Lantus on anti-insulin antibody development after 24 weeks of treatment. This change from baseline reflects the Week 24 AIA titer minus the Week 0 AIA titer.

  Baseline and Week 24

• Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 24

  Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 24. This immunogenicity analysis assessed the effect of treatment with MK-1293 and with Lantus on insulin-neutralizing antibody (INab) development up through 24 weeks of treatment.

  Up to Week 24

Secondary Outcomes (23)

• Change From Baseline in A1C at Week 52

  Baseline and Week 52

• Total Insulin Dose at Week 24

  Week 24

• Total Insulin Dose Per Kilogram (kg) of Body Weight (Unit/kg) at Week 24

  Week 24

• Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

  Baseline and Week 24

• Percentage of Participants With Confirmed Positive AIA Up Through Week 52

  Up to Week 52 including baseline

Study Arms (2)

MK-1293

EXPERIMENTAL

MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post randomization to the suggested target for fasting fingerstick glucose levels of \>70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).

Drug: MK-1293; Drug: Prandial Insulin

Lantus

ACTIVE COMPARATOR

Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of \>70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).

Drug: Lantus™; Drug: Prandial Insulin

Interventions

MK-1293 DRUG

MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Initial dose will be determined based on the participant's previous insulin therapy. Thereafter, the dose will be titrated to the suggested target for fasting fingerstick glucose levels. 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™ dosed subcutaneously once daily at bedtime for 52 weeks. Initial dose will be determined based on the participant's previous insulin therapy. Thereafter, the dose will be titrated to the suggested target for fasting fingerstick glucose levels. 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

Lantus

Prandial Insulin DRUG

Participants will continue their prandial insulin during the study.

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:

• T1DM For at least 1 year
• is currently using or has been using prandial insulin for at least 4 weeks. Participants taking any type of basal insulin should require a total daily dose of \>=10 units/day. For participants currently taking pre-mixed insulin, the basal insulin component should be equivalent to a total daily dose of \>=10 units/day.
• is male, or is female who is not of reproductive potential or if of reproductive potential agrees to remain abstinent or use (or have their partner use) an acceptable method of birth control during the study and for 14 days after the last dose of study medication

You may not qualify if:

• has had 1 or more severe hypoglycemic episodes associated with hypoglycemic seizure or loss of consciousness within the past 6 months
• history of ketoacidosis in the last 6 months
• participant, as assessed by the investigator, is not appropriate for or does not agree to target a fasting glucose of 70-100 mg/dL \[3.9 -5.6 mmol/L\].
• history of intolerance or hypersensitivity to Lantus™ or contraindication to Lantus™ or one of its excipients
• used a formulation of insulin glargine other than Lantus™
• has received injectable incretin-based therapy within the past 8 weeks
• on a weight loss program and not in the maintenance phase, or has started a weight loss medication within the past 8 weeks
• has undergone bariatric surgery within the past 12 months
• is likely to require treatment for 2 or more consecutive weeks or repeated courses of corticosteroids (note: inhaled, nasal, and topical corticosteroids are permitted)
• has undergone a surgical procedure within the past 4 weeks or has planned major surgery during the study
• has new or worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months, or has any following disorders within the past 3 months: acute coronary syndrome, coronary artery intervention, stroke or transient ischemic neurological disorder
• has severe peripheral vascular disease
• has high blood pressure
• has chronic myopathy, or a progressive neurological or neuromuscular disorder
• has active nephropathy

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Home PD, Lam RLH, Carofano WL, Golm GT, Eldor R, Crutchlow MF, Marcos MC, Rosenstock J, Hollander PA, Gallwitz B. Efficacy and safety of MK-1293 insulin glargine compared with originator insulin glargine (Lantus) in type 1 diabetes: A randomized, open-label clinical trial. Diabetes Obes Metab. 2018 Sep;20(9):2220-2228. doi: 10.1111/dom.13354. Epub 2018 Jun 5.

  PMID: 29766635 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

MK-1293; Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune 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: October 17, 2013
• Primary Completion: May 4, 2015
• Study Completion: November 12, 2015
• Last Updated: September 5, 2018
• Results First Posted: March 8, 2017

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share