Type 1 Diabetes MellitusPhase 3NCT02059161

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

A Phase 3 study testing MK-1293, Lantus™ and Prandial Insulin in people with Type 1 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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™. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 1 Diabetes Mellitus
What is being tested?: MK-1293, Lantus™ and Prandial Insulin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 508 participants
Where: No sites listed yet
Study dates: 17 Oct 2013to 12 Nov 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 25Show fewer

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
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
has human immunodeficiency virus (HIV)
has a hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
history of malignancy in the past 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
history of melanoma, leukemia, lymphoma, or renal cell carcinoma
is currently being treated for hyperthyroidism or has been on a stable dose of thyroid hormone replacement therapy for <6 weeks
is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence
is pregnant or breast-feeding, or is expecting to conceive or donate eggs
has donated blood products or has had phlebotomy of >300 mL within the past 8 weeks or intends to donate blood products during the study
has poor mental function or works the night shift

About this study

Official title: A Phase III Clinical Trial to Study the Safety and Efficacy of MK-1293 Compared to Lantus™ in Subjects With Type 1 Diabetes Mellitus

Conditions: Type 1 Diabetes Mellitus
Being tested: MK-1293, Lantus™, Prandial Insulin
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MK-1293Drug
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.
Lantus™Drug
Also called Insulin glargine
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.
Prandial InsulinDrug
Participants will continue their prandial insulin during the study.

Study groups in NCT02059161
Study group	Role	What they receive
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). Receives: 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). Receives: Drug: Lantus™; Drug: Prandial Insulin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Week 24

Secondary outcomes (23)

Change From Baseline in A1C at Week 52
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 52 A1C minus the Week 0 A1C.
Measured: Baseline and Week 52
Total Insulin Dose at Week 24
Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication).
Measured: Week 24
Total Insulin Dose Per Kilogram (kg) of Body Weight (Unit/kg) at Week 24
Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication).
Measured: Week 24
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Blood glucose was measured on a fasting basis (collected after a 10-hour fast). FPG is expressed as mg/dL. This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.
Measured: Baseline and Week 24
Percentage of Participants With Confirmed Positive AIA Up Through Week 52
Percentage of participants with confirmed positive AIA at any time up through Week 52 including baseline.
Measured: Up to Week 52 including baseline
Percentage of Participants With Negative AIA at Baseline Who Develop Confirmed Positive AIA at Any Time Up Through Week 52
Percentage of participants who became positive to AIA at or before Week 52, among participants who were AIA negative at baseline.
Measured: Up to Week 52
Change From Baseline in AIA Titer After 52 Weeks of Treatment
This immunogenicity analysis assessed the effect of treatment with MK-1293 compared with Lantus on anti-insulin antibody development after 52 weeks of treatment. This change from baseline reflects the AIA titers at Week 52 minus the AIA titers at Week 0.
Measured: Baseline and Week 52
Total Insulin Dose at Week 52
Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication).
Measured: Week 52
Total Insulin Dose Per Kilogram (kg) of Body Weight (Unit/kg) at Week 52
Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication).
Measured: Week 52
Change From Baseline in FPG at Week 52
Blood glucose was measured on a fasting basis (collected after a 10-hour fast). This change from baseline reflects the FPG level at Week 52 minus the FPG level at Week 0.
Measured: Baseline and Week 52
Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 52
Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Thought Week 52. This immunogenicity analysis assessed the effect of treatment with MK-1293 and with Lantus on insulin-neutralizing antibody (INAb) development up through 52 weeks of treatment.
Measured: Up to Week 52
Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) at Week 24
The 7-point SMBG profile consisted of the following measurements by glucose meter: morning pre-meal (fasting), 2 hours after morning meal, midday pre-meal, 2 hours after midday meal, evening pre meal, pre-bedtime (pre-dose and at least 2 hours after evening meal), between 2:00 AM and 4:00 AM in the morning.
Measured: Baseline and Week 24
Change From Baseline in 7-point SMBG at Week 52
The 7-point SMBG profile consisted of the following measurements by glucose meter: morning pre-meal (fasting), 2 hours after morning meal, midday pre-meal, 2 hours after midday meal, evening pre meal, pre-bedtime (pre-dose and at least 2 hours after evening meal), between 2:00 AM and 4:00 AM in the morning.
Measured: Baseline and Week 52
Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% After 24 Weeks of Treatment.
Percentage of participants attaining A1C glycemic goals of <7.0% and <6.5% after 24 weeks of treatment.
Measured: 24 weeks
Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% After 52 Weeks of Treatment.
Percentage of participants attaining A1C glycemic goals of <7.0% and <6.5% after 52 weeks of treatment.
Measured: 52 weeks
Basal Insulin Dose at Week 52
Basal Insulin Dose at Week 52.
Measured: Week 52
Basal Insulin Dose Per kg of Body Weight at Week 52
Basal Insulin Dose per kg of Body Weight at Week 52.
Measured: Week 52
Bolus Insulin Dose at Week 52
Bolus Insulin Dose at Week 52.
Measured: Week 52
Bolus Insulin Dose Per kg of Body Weight at Week 52
Bolus Insulin Dose per kg of Body Weight at Week 52.
Measured: Week 52
Basal Insulin Dose at Week 24
Basal Insulin Dose at Week 24.
Measured: Week 24
Basal Insulin Dose Per kg of Body Weight at Week 24
Basal Insulin Dose per kg of Body Weight at Week 24.
Measured: Week 24
Bolus Insulin Dose at Week 24
Bolus Insulin Dose at Week 24.
Measured: Week 24
Bolus Insulin Dose Per kg of Body Weight at Week 24
Bolus Insulin Dose per kg of Body Weight at Week 24.
Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Oct 201312 Nov 2015

First posted11 Feb 2014 (estimated)
Study start17 Oct 2013
Primary completion4 May 2015
Study completion12 Nov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 508 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02059161
Sponsor's protocol ID: 1293-003
Other IDs: 2011-003971-12
Status last verified: Aug 2018
First submitted: 7 Feb 2014
Last updated: 5 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

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.
PubMed 29766635

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Clinical Trial to Study the Safety and Efficacy of MK-1293 Compared to Lantus™ in Subjects With Type 1 Diabetes Mellitus
ClinicalTrials.gov ID: NCT02059161
Acronym / sponsor ID: 1293-003
Conditions: Type 1 Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 508 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 17 Oct 2013 (actual)
Primary completion: 4 May 2015 (actual)
Study completion: 12 Nov 2015 (actual)
First posted: 11 Feb 2014 (estimated)
Results: Posted 8 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
MK-1293	Experimental	Drug: MK-1293, Drug: Prandial InsulinMK-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).
Lantus	Active comparator	Drug: Lantus™, Drug: Prandial InsulinLantus 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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (25 listed)

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™

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MK-1293MK-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.	Drug	MK-1293
Lantus™Also: Insulin glargineLantus™ 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.	Drug	Lantus
Prandial InsulinParticipants will continue their prandial insulin during the study.	Drug	Lantus, MK-1293

Primary outcome

Primary: Change From Baseline in Hemoglobin A1c (A1C) at Week 24
Time frame: Baseline and 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.
Percentage of Participants With Any Confirmed Positive Anti-insulin Antibody (AIA) at Any Time Up Through Week 24
Time frame: Up to Week 24
Percentage of participants with confirmed positive AIA at any time up through Week 24 including baseline.
Percentage of Participants With Negative AIA at Baseline Who Develop Confirmed Positive AIA at Any Time Up Through Week 24
Time frame: Up to Week 24
Percentage of participants who became positive to AIA at or before Week 24, among participants who were AIA negative at baseline.
Change From Baseline in AIA Titer After 24 Weeks of Treatment
Time frame: Baseline and Week 24
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.
Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 24
Time frame: Up to 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.

23 secondary outcomes

Change From Baseline in A1C at Week 52
Time frame: Baseline and Week 52
Total Insulin Dose at Week 24
Time frame: Week 24
Total Insulin Dose Per Kilogram (kg) of Body Weight (Unit/kg) at Week 24
Time frame: Week 24
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Time frame: Baseline and Week 24
Percentage of Participants With Confirmed Positive AIA Up Through Week 52
Time frame: Up to Week 52 including baseline
Percentage of Participants With Negative AIA at Baseline Who Develop Confirmed Positive AIA at Any Time Up Through Week 52
Time frame: Up to Week 52
Change From Baseline in AIA Titer After 52 Weeks of Treatment
Time frame: Baseline and Week 52
Total Insulin Dose at Week 52
Time frame: Week 52
Total Insulin Dose Per Kilogram (kg) of Body Weight (Unit/kg) at Week 52
Time frame: Week 52
Change From Baseline in FPG at Week 52
Time frame: Baseline and Week 52
Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 52
Time frame: Up to Week 52
Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) at Week 24
Time frame: Baseline and Week 24
Change From Baseline in 7-point SMBG at Week 52
Time frame: Baseline and Week 52
Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% After 24 Weeks of Treatment.
Time frame: 24 weeks
Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% After 52 Weeks of Treatment.
Time frame: 52 weeks
Basal Insulin Dose at Week 52
Time frame: Week 52
Basal Insulin Dose Per kg of Body Weight at Week 52
Time frame: Week 52
Bolus Insulin Dose at Week 52
Time frame: Week 52
Bolus Insulin Dose Per kg of Body Weight at Week 52
Time frame: Week 52
Basal Insulin Dose at Week 24
Time frame: Week 24
Basal Insulin Dose Per kg of Body Weight at Week 24
Time frame: Week 24
Bolus Insulin Dose at Week 24
Time frame: Week 24
Bolus Insulin Dose Per kg of Body Weight at Week 24
Time frame: Week 24

Results and safety

Results posted to the registry on 8 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK-1293	245	196
Lantus	263	222

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

Time frame: Baseline and Week 24. Least squares mean (95% Confidence Interval). Unit: Percent

Measure	MK-1293 n = 241	Lantus n = 258
Value	-0.62 (-0.79 to -0.45)	-0.66 (-0.82 to -0.50)

MK-1293 vs Lantus: Difference in the Least Squares Means: 0.04 (95% CI -0.11 to 0.19)

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

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

Time frame: Up to Week 24. Number. Unit: Percentage of participants

Measure	MK-1293 n = 241	Lantus n = 258
Value	70.1	74.0

MK-1293 vs Lantus: Difference in the Percentages: -3.9 (95% CI -11.8 to 4.0)

Population analysed: The analysis population included all randomized, treated participants who had data for AIA at or before Week 24.

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

Time frame: Up to Week 24. Number. Unit: Percentage of participants

Measure	MK-1293 n = 101	Lantus n = 98
Value	32.7	35.7

MK-1293 vs Lantus: Difference in Percentages: -3.0 (95% CI -16.1 to 10.1)

Population analysed: The analysis population included all randomized, treated participants who were AIA negative at baseline and had data for AIA at or before Week 24.

Primary outcome: Change From Baseline in AIA Titer After 24 Weeks of Treatment

Time frame: Baseline and Week 24. Mean (Standard Deviation). Unit: AIA Titers

Measure	MK-1293 n = 185	Lantus n = 198
Value	0.4 (15.9)	0.3 (23.2)

Population analysed: The analysis population included all randomized, treated participants who had AIA data at baseline and Week 24.

23 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 54 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK-1293	23 of 241 (9.5%)	190 of 241 (78.8%)	Not reported
Lantus	30 of 258 (11.6%)	216 of 258 (83.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29766635Home 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.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MK-1293, Lantus™ and Prandial Insulin in people with Type 1 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary: Change From Baseline in Hemoglobin A1c (A1C) at Week 24 (time frame: Baseline and Week 24). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02059161, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.