Phase 3
Completed N=531
The Safety and Efficacy of MK-1293 Versus Lantus™ in Participants With Type 2 Diabetes Mellitus (MK-1293-006)
Source: ClinicalTrials.gov NCT02059187 ↗Enrolled (actual)
531
Serious AEs
4.2%
Results posted
Mar 2017
Primary outcomePrimary: Change From Baseline in Participant Hemoglobin A1C Level at Week 24 — -1.28; -1.30 Percent A1C
◆ Published Evidence
Emerging
13citations · ~2 / year
Efficacy and safety of MK-1293 insulin glargine compared with originator insulin glargine (Lantus) in type 2 diabetes: A randomized, open-label clinical 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 with that in participants treated with Lantus™.
Linked Publications
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Efficacy and safety of MK-1293 insulin glargine compared with originator insulin glargine (Lantus) in type 2 diabetes: A randomized, open-label clinical trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Participant Hemoglobin A1C Level at Week 24 |
-1.28; -1.30 | — |
| PRIMARY Percentage of Participants With Confirmed Anti-Insulin Antibodies (AIA) up to Week 24 |
34.7; 29.0 | — |
| SECONDARY Change From Baseline in Participant Body Weight at Week 24 |
1.3; 1.4 | — |
| SECONDARY Percentage of Participants Experiencing an Adverse Event (AE) of Hypoglycemia Up to Week 24 |
54.0; 54.0 | — |
| SECONDARY Percentage of Participants Experiencing an AE Over the 24-week Treatment Period |
78.3; 71.5 | — |
| SECONDARY Daily Basal Insulin Dose (Units) at Week 24 |
48.2; 46.9 | — |
| SECONDARY Daily Basal Insulin Dose Per Body Weight (Units/kg) at Week 24 |
0.53; 0.51 | — |
| SECONDARY Change From Baseline in Participant Fasting Plasma Glucose (FPG) at Week 24 |
-35.0; -38.4 | — |
| SECONDARY Change From Baseline in Participant 7-Point Average of Self-Monitored Blood Glucose (SMBG) at Week 24 |
-30.7; -27.3 | — |
| SECONDARY Percentage of Participants With Hemoglobin A1C <7% at Week 24 |
46.5; 43.7 | — |
| SECONDARY Percentage of Participants With Hemoglobin A1C <6.5% at Week 24 |
21.6; 22.4 | — |
Eligibility 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) 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™
Data sourced from ClinicalTrials.gov (NCT02059187) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.