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™.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
531
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™ (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.
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.
Time frame: 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.
Time frame: Up to 24 weeks
Change From Baseline in Participant Body Weight at Week 24
Change from baseline in participant body weight at Week 24.
Time frame: Baseline and Week 24
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.
Time frame: Up to 24 weeks
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.
Time frame: Up to 24 weeks
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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.
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.
Time frame: Week 24
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).
Time frame: Week 24
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.
Time frame: Baseline and Week 24
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.
Time frame: Baseline and Week 24
Percentage of Participants With Hemoglobin A1C <7% at Week 24
Percentage of participants with A1C \<7.0% (53 mmol/mol) at Week 24.
Time frame: Week 24
Percentage of Participants With Hemoglobin A1C <6.5% at Week 24
Percentage of participants with A1C \<6.5% (48 mmol/mol) at Week 24.
Time frame: Week 24