Trial Outcomes & Findings for The Safety and Efficacy of MK-1293 Versus Lantus™ in Participants With Type 2 Diabetes Mellitus (MK-1293-006) (NCT NCT02059187)

NCT ID: NCT02059187

Last Updated: 2018-09-06

Results Overview

A1C is measured as a percent. A1C is the key glycemic parameter which correlates with reduction of risk of diabetic complications.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 531 participants
• Primary outcome timeframe: Baseline and Week 24
• Results posted on: 2018-09-06

Participant Flow

Participant milestones

Measure	MK-1293 MK-1293 administered subcutaneously once daily.	Lantus™ Lantus™ administered subcutaneously once daily.
Overall Study STARTED	265	266
Overall Study COMPLETED	240	244
Overall Study NOT COMPLETED	25	22

Reasons for withdrawal

Measure	MK-1293 MK-1293 administered subcutaneously once daily.	Lantus™ Lantus™ administered subcutaneously once daily.
Overall Study Adverse Event	0	3
Overall Study Death	1	1
Overall Study Lost to Follow-up	9	8
Overall Study Non-compliance with study drug	1	0
Overall Study Physician Decision	1	2
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	12	8

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	MK-1293 n=265 Participants MK-1293 administered subcutaneously once daily.	Lantus™ n=266 Participants Lantus™ administered subcutaneously once daily.	Total n=531 Participants Total of all reporting groups
Age, Continuous	56.9 Years STANDARD_DEVIATION 10.0 • n=5 Participants	57.1 Years STANDARD_DEVIATION 9.8 • n=7 Participants	57.0 Years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	113 Participants n=5 Participants	125 Participants n=7 Participants	238 Participants n=5 Participants
Sex: Female, Male Male	152 Participants n=5 Participants	141 Participants n=7 Participants	293 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.

A1C is measured as a percent. A1C is the key glycemic parameter which correlates with reduction of risk of diabetic complications.

Outcome measures

Measure	MK-1293 n=263 Participants MK-1293 administered subcutaneously once daily.	Lantus™ n=263 Participants Lantus™ administered subcutaneously once daily.
Change From Baseline in Participant Hemoglobin A1C Level at Week 24	-1.28 Percent A1C Interval -1.41 to -1.15	-1.30 Percent A1C Interval -1.43 to -1.18

PRIMARY outcome

Timeframe: Up to 24 weeks

Population: The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.

Percentage of participants is a cumulative percentage of participants with any confirmed AIA (including baseline) up to Week 24.

Outcome measures

Measure	MK-1293 n=262 Participants MK-1293 administered subcutaneously once daily.	Lantus™ n=262 Participants Lantus™ administered subcutaneously once daily.
Percentage of Participants With Confirmed Anti-Insulin Antibodies (AIA) up to Week 24	34.7 Percentage of participants	29.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.

Change from baseline in participant body weight at Week 24.

Outcome measures

Measure	MK-1293 n=242 Participants MK-1293 administered subcutaneously once daily.	Lantus™ n=246 Participants Lantus™ administered subcutaneously once daily.
Change From Baseline in Participant Body Weight at Week 24	1.3 kilograms Standard Deviation 3.6	1.4 kilograms Standard Deviation 4.5

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: All randomized participants who received at least one dose of study treatment.

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.

Outcome measures

Measure	MK-1293 n=263 Participants MK-1293 administered subcutaneously once daily.	Lantus™ n=263 Participants Lantus™ administered subcutaneously once daily.
Percentage of Participants Experiencing an Adverse Event (AE) of Hypoglycemia Up to Week 24	54.0 Percentage of participants	54.0 Percentage of participants

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: All randomized participants who received at least one dose of study treatment.

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.

Outcome measures

Measure	MK-1293 n=263 Participants MK-1293 administered subcutaneously once daily.	Lantus™ n=263 Participants Lantus™ administered subcutaneously once daily.
Percentage of Participants Experiencing an AE Over the 24-week Treatment Period	78.3 Percentage of participants	71.5 Percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.

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.

Outcome measures

Measure	MK-1293 n=263 Participants MK-1293 administered subcutaneously once daily.	Lantus™ n=262 Participants Lantus™ administered subcutaneously once daily.
Daily Basal Insulin Dose (Units) at Week 24	48.2 Units Interval 44.9 to 51.5	46.9 Units Interval 43.5 to 50.2

SECONDARY outcome

Timeframe: Week 24

Population: The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.

Basal insulin dose per body weight was calculated as total insulin dose (units) per day divided by body weight in kilograms (kg).

Outcome measures

Measure	MK-1293 n=263 Participants MK-1293 administered subcutaneously once daily.	Lantus™ n=262 Participants Lantus™ administered subcutaneously once daily.
Daily Basal Insulin Dose Per Body Weight (Units/kg) at Week 24	0.53 Units/kg Interval 0.49 to 0.56	0.51 Units/kg Interval 0.48 to 0.54

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.

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.

Outcome measures

Measure	MK-1293 n=263 Participants MK-1293 administered subcutaneously once daily.	Lantus™ n=263 Participants Lantus™ administered subcutaneously once daily.
Change From Baseline in Participant Fasting Plasma Glucose (FPG) at Week 24	-35.0 mg/dL Interval -41.3 to -28.6	-38.4 mg/dL Interval -44.8 to -32.1

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.

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.

Outcome measures

Measure	MK-1293 n=246 Participants MK-1293 administered subcutaneously once daily.	Lantus™ n=235 Participants Lantus™ administered subcutaneously once daily.
Change From Baseline in Participant 7-Point Average of Self-Monitored Blood Glucose (SMBG) at Week 24	-30.7 mg/dL Interval -37.6 to -23.8	-27.3 mg/dL Interval -34.0 to -20.5

SECONDARY outcome

Timeframe: Week 24

Population: The analysis population included all randomized, treated participants with a Week 24 A1C measurement.

Percentage of participants with A1C <7.0% (53 mmol/mol) at Week 24.

Outcome measures

Measure	MK-1293 n=241 Participants MK-1293 administered subcutaneously once daily.	Lantus™ n=245 Participants Lantus™ administered subcutaneously once daily.
Percentage of Participants With Hemoglobin A1C <7% at Week 24	46.5 Percentage of participants	43.7 Percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: The analysis population included all randomized, treated participants with a Week 24 A1C measurement.

Percentage of participants with A1C <6.5% (48 mmol/mol) at Week 24.

Outcome measures

Measure	MK-1293 n=241 Participants MK-1293 administered subcutaneously once daily.	Lantus™ n=245 Participants Lantus™ administered subcutaneously once daily.
Percentage of Participants With Hemoglobin A1C <6.5% at Week 24	21.6 Percentage of participants	22.4 Percentage of participants

Adverse Events

MK-1293

Serious events: 13 serious events

Other events: 147 other events

Deaths: 0 deaths

Lantus™

Serious events: 9 serious events

Other events: 151 other events

Deaths: 0 deaths

Serious adverse events

Measure	MK-1293 n=263 participants at risk MK-1293 administered subcutaneously once daily.	Lantus™ n=263 participants at risk Lantus™ administered subcutaneously once daily.
Infections and infestations Sepsis	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Infections and infestations Staphylococcal abscess	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Road traffic accident	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypoglycaemia	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Cardiac disorders Angina pectoris	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Cardiac disorders Angina unstable	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Cardiac disorders Cardiac failure congestive	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Cardiac disorders Coronary artery disease	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Cardiac disorders Coronary artery stenosis	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Cardiac disorders Mitral valve disease mixed	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Cardiac disorders Myocardial ischaemia	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Cardiac disorders Palpitations	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Eye disorders Vitreous haemorrhage	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
General disorders Non-cardiac chest pain	0.76% 2/263 • Number of events 2 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Immune system disorders Anaphylactic reaction	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Infections and infestations Cellulitis	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Infections and infestations Gastroenteritis	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Infections and infestations Pneumonia	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Nervous system disorders Cerebral small vessel ischaemic disease	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Nervous system disorders Cerebrovascular accident	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Nervous system disorders Headache	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Nervous system disorders Lumbar radiculopathy	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Nervous system disorders Transient ischaemic attack	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Acute kidney injury	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Reproductive system and breast disorders Prostatomegaly	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pickwickian syndrome	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Vascular disorders Shock	0.00% 0/263 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	0.38% 1/263 • Number of events 1 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.

Other adverse events

Measure	MK-1293 n=263 participants at risk MK-1293 administered subcutaneously once daily.	Lantus™ n=263 participants at risk Lantus™ administered subcutaneously once daily.
Infections and infestations Upper respiratory tract infection	6.1% 16/263 • Number of events 16 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	5.7% 15/263 • Number of events 16 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypoglycaemia	54.0% 142/263 • Number of events 1352 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.	54.0% 142/263 • Number of events 1141 • Up to 26 weeks (including 2-week follow-up for serious adverse events) All randomized participants who received at least one dose of study treatment.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
• Publication restrictions are in place

Restriction type: OTHER