Randomized Sitagliptin Withdrawal Study (MK-0431-845)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02738879
• Date of registration: 11/04/2016
• Prospective Registration: Yes
• Primary sponsor: Merck Sharp & Dohme Corp.
• Public title: Randomized Sitagliptin Withdrawal Study (MK-0431-845)
• Scientific title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of the Continuation of Sitagliptin Compared With the Withdrawal of Sitagliptin During Initiation and Titration of Insulin Glargine (LANTUS®) in Subjects With Type 2 Diabetes Mellitus
• Date of first enrolment: May 9, 2016
• Target sample size: 746
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02738879
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Canada, Czech Republic, Czechia, Denmark, Estonia, France, Germany, Guatemala, Hungary, Israel, Korea, Republic of, Latvia, Mexico, New Zealand, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Spain, Turkey, United Kingdom, United States

Contacts

• Name: Medical Director
• Affiliation: Merck Sharp & Dohme Corp.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Have T2DM based on American Diabetes Association guidelines

- Be on one of the following treatment regimens:

1. Stable dose of sitagliptin (100 mg/day) and metformin IR or XR (metformin) (=1500
mg/day) either co-administered or as a fixed dose combination (FDC) for =12 weeks
with A1C between 7.5% and 11.0%, inclusive.

OR

2. Stable dose of metformin (=1500 mg/day) and another dipeptidyl peptidase-4
(DPP-4) inhibitor (at maximum labeled dose, other than sitagliptin, either
co-administered or as a FDC, for =12 weeks with A1C between 7.5% and 11.0%,
inclusive.

OR

3. Stable dose of sitagliptin (100 mg/day) and metformin (=1500 mg/day) either co
administered or as a FDC, and a sulfonylurea for =12 weeks OR stable dose of
metformin (=1500 mg/day) and a sulfonylurea administered as a FDC and sitagliptin
(100 mg/day) with A1C between 7.0% and 10.0%, inclusive.

OR

4. Stable dose of metformin (=1500 mg/day) and another DPP-4 inhibitor (at maximum
labeled dose), other than sitagliptin, either co-administered or as a FDC, and a
sulfonylurea for =12 weeks OR stable dose of metformin (=1500 mg/day) and a
sulfonylurea administered as a FDC and another DPP-4 inhibitor other than
sitagliptin with A1C between 7.0% and 10.0%, inclusive OR

5. Stable dose of metformin (=1500 mg/day) and a sulfonylurea either co-administered
or as a FDC for =12 weeks with A1C between 7.5% and 11.0%, inclusive.

- Meet one of the following categories:

1. The participant is a male

2. The participant is a female who is not of reproductive potential

3. The participant is a female who is of reproductive potential and agrees to avoid
becoming pregnant while receiving study drug and for 14 days after the last dose
of study drug by practicing abstinence from heterosexual activity OR use (or have
her partner use) acceptable contraception during heterosexual activity

Exclusion Criteria:

- Has been treated with any anti-hyperglycemic agent (AHA) other than protocol-specified
agents (i.e., other than metformin, DPP-4 inhibitor, or sulfonylurea agent) within the
prior 12 weeks.

- Has a history of 2 or more episodes of hypoglycemia resulting in seizure, coma, or
loss of consciousness, OR has had recurrent (=3 times per week) episodes of
hypoglycemia over the past 8 weeks.

- Has a history of type 1 diabetes mellitus (T1DM) or ketoacidosis, or has a history of
latent autoimmune diabetes of adults (LADA), is assessed by the investigator as
possibly having T1DM or LADA confirmed with a C-peptide <0.7 ng/mL (<0.23 nmol/L), or
has a history of other specific types of diabetes (e.g., genetic syndromes, secondary
pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, or
post-organ transplant).

- Is assessed by the investigator to be not appropriate for, or does not agree to
target, a fasting glucose of 72-100 mg/dL (4.0-5.6 mmol/L).



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

Drug: Metformin XR

Drug: Insulin glargine

Drug: Sitagliptin

Drug: Metformin

Drug: Placebo to sitagliptin

Primary Outcome(s)

Event Rate of Documented Symptomatic Hypoglycemia With Blood Glucose =70 mg/dL (=3.9 mmol/L) [Time Frame: Up to 30 weeks]

Percentage of Participants Who Discontinued Study Drug Due to an AE [Time Frame: Up to 30 weeks]

Change From Baseline in A1C at Week 30 [Time Frame: Baseline and Week 30]

Percentage of Participants Who Experienced One or More Adverse Events (AEs) [Time Frame: Up to 32 weeks]

Secondary Outcome(s)

Percentage of Participants With Documented Hypoglycemia With Blood Glucose =70 mg/dL (=3.9 mmol/L) [Time Frame: Up to 30 weeks]

Change From Baseline in Total Daily Insulin Dose (Units) at Week 30 [Time Frame: Baseline and Week 30]

Event Rate of Documented Hypoglycemia With Blood Glucose <56 mg/dL (=3.1 mmol/L) [Time Frame: Up to 30 weeks]

Event Rate of Documented Symptomatic Hypoglycemia With Blood Glucose <56 mg/dL (=3.1 mmol/L) [Time Frame: Up to 30 weeks]

Percentage of Participants With Documented Hypoglycemia With Blood Glucose <56 mg/dL (=3.1 mmol/L) [Time Frame: Up to 30 weeks]

Percentage of Participants With A1C Goal <7.0% (<53 mmol/Mol at Week 30 and No Documented Hypoglycemia With Blood Glucose =70 mg/dL (=3.9 mmol/L) up to Week 30 [Time Frame: Week 30]

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30 [Time Frame: Baseline and Week 30]

Percentage of Participants With A1C Goal <7.0% (<53 mmol/Mol) at Week 30 [Time Frame: Week 30]

Percentage of Participants With Documented Symptomatic Hypoglycemia With Blood Glucose <56 mg/dL (=3.1 mmol/L) [Time Frame: Up to 30 weeks]

Percentage of Participants With Events of Documented Symptomatic Hypoglycemia With Blood Glucose =70 mg/dL (=3.9 mmol/L) [Time Frame: Up to 30 weeks]

Event Rate of Documented Hypoglycemia With Blood Glucose =70 mg/dL (=3.9 mmol/L) [Time Frame: Up to 30 weeks]

Secondary ID(s)

MK-0431-845

0431-845

2015-004990-34

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 25/02/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02738879