Trial Outcomes & Findings for Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Participants With Type 2 Diabetes Mellitus Receiving Acarbose Monotherapy (MK-0431-130) (NCT NCT01177384)

Last Updated: 2018-08-16

Results Overview

A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent. Efficacy analyses treated data as missing after the initiation of rescue therapy.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

380 participants

Primary outcome timeframe

Baseline and Week 24

Results posted on

2018-08-16

Participant Flow

All participants randomized population. The participant flow module includes the second sequential randomization of a participant in the placebo group. Data for the second sequential randomization were excluded from the efficacy and safety analyses and the reason for not completed was a protocol violation.

Participant milestones

Participant milestones
Measure	Sitagliptin Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily \[t.i.d.\])	Placebo Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
Overall Study STARTED	191	190
Overall Study COMPLETED	177	164
Overall Study NOT COMPLETED	14	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Sitagliptin Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily \[t.i.d.\])	Placebo Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
Overall Study Adverse Event	6	4
Overall Study Lack of Efficacy	0	1
Overall Study Lost to Follow-up	3	4
Overall Study Physician Decision	0	3
Overall Study Protocol Violation	0	2
Overall Study Withdrawal by Subject	5	12

Baseline Characteristics

Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Participants With Type 2 Diabetes Mellitus Receiving Acarbose Monotherapy (MK-0431-130)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sitagliptin n=191 Participants Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily \[t.i.d.\])	Placebo n=189 Participants Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)	Total n=380 Participants Total of all reporting groups
Age, Continuous	56.5 Years STANDARD_DEVIATION 8.9 • n=99 Participants	57.8 Years STANDARD_DEVIATION 9.5 • n=107 Participants	57.1 Years STANDARD_DEVIATION 9.2 • n=206 Participants
Sex: Female, Male Female	94 Participants n=99 Participants	92 Participants n=107 Participants	186 Participants n=206 Participants
Sex: Female, Male Male	97 Participants n=99 Participants	97 Participants n=107 Participants	194 Participants n=206 Participants
Hemoglobin A1c (A1C)	8.09 Percent STANDARD_DEVIATION 0.79 • n=99 Participants	8.08 Percent STANDARD_DEVIATION 0.90 • n=107 Participants	8.08 Percent STANDARD_DEVIATION 0.85 • n=206 Participants
Fasting plasma glucose	177.3 mg/dL STANDARD_DEVIATION 37.5 • n=99 Participants	177.5 mg/dL STANDARD_DEVIATION 40.2 • n=107 Participants	177.4 mg/dL STANDARD_DEVIATION 38.8 • n=206 Participants

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: Full Analysis Set, all randomized participants except those who: failed to take at least 1 dose of study treatment, lacked all post-randomization data for the A1C subsequent to at least 1 dose of study treatment, or lacked baseline data for the A1C. Last observation carried forward (missing data approach).

Outcome measures

Outcome measures
Measure	Sitagliptin n=185 Participants Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily \[t.i.d.\])	Placebo n=180 Participants Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
Change From Baseline in Hemoglobin A1c (A1C) at Week 24	-0.76 Percent Interval -0.93 to -0.59	-0.14 Percent Interval -0.32 to 0.03

PRIMARY outcome

Timeframe: Up to Week 24 + 14 Day Post-Study Follow-up

Population: All participants as treated population defined as all randomized participants who received at least one dose of study drug. Data were excluded after the initiation of rescue therapy.

Outcome measures

Outcome measures
Measure	Sitagliptin n=191 Participants Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily \[t.i.d.\])	Placebo n=189 Participants Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
Number of Participants Who Experienced at Least One Adverse Event	62 Participants	58 Participants

PRIMARY outcome

Timeframe: Up to 24 Weeks

Population: All participants as treated population defined as all randomized participants who received at least one dose of study drug. Data were excluded after the initiation of rescue therapy.

Outcome measures

Outcome measures
Measure	Sitagliptin n=191 Participants Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily \[t.i.d.\])	Placebo n=189 Participants Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
Number of Participants Who Discontinued Study Drug Due to an Adverse Event	5 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full Analysis Set, all randomized participants except those who: failed to take at least 1 dose of study treatment, lacked all post-randomization data for the FPG subsequent to at least 1 dose of study treatment, or lacked baseline data for the FPG. Last observation carried forward (missing data approach).

Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG. Efficacy analyses treated data as missing after the initiation of rescue therapy.

Outcome measures

Outcome measures
Measure	Sitagliptin n=187 Participants Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily \[t.i.d.\])	Placebo n=183 Participants Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	-17.9 mg/dL Interval -25.3 to -10.5	-3.5 mg/dL Interval -11.1 to 4.1

Adverse Events

Sitagliptin

Serious events: 10 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sitagliptin n=191 participants at risk Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily \[t.i.d.\])	Placebo n=189 participants at risk Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
Cardiac disorders Cardia flutter	0.52% 1/191 • Number of events 1 All participants as treated population. Participants received rescue therapy if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue therapy. Other adverse events only include those AEs that occurred prior to a participant receiving rescue therapy.	0.00% 0/189 All participants as treated population. Participants received rescue therapy if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue therapy. Other adverse events only include those AEs that occurred prior to a participant receiving rescue therapy.
Gastrointestinal disorders Pancreatitis chronic	0.52% 1/191 • Number of events 1 All participants as treated population. Participants received rescue therapy if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue therapy. Other adverse events only include those AEs that occurred prior to a participant receiving rescue therapy.	0.00% 0/189 All participants as treated population. Participants received rescue therapy if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue therapy. Other adverse events only include those AEs that occurred prior to a participant receiving rescue therapy.
Hepatobiliary disorders Bile duct stone	0.52% 1/191 • Number of events 1 All participants as treated population. Participants received rescue therapy if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue therapy. Other adverse events only include those AEs that occurred prior to a participant receiving rescue therapy.	0.00% 0/189 All participants as treated population. Participants received rescue therapy if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue therapy. Other adverse events only include those AEs that occurred prior to a participant receiving rescue therapy.
Hepatobiliary disorders Cholecystitis	1.0% 2/191 • Number of events 2 All participants as treated population. Participants received rescue therapy if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue therapy. Other adverse events only include those AEs that occurred prior to a participant receiving rescue therapy.	0.00% 0/189 All participants as treated population. Participants received rescue therapy if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue therapy. Other adverse events only include those AEs that occurred prior to a participant receiving rescue therapy.
Infections and infestations Gastroenteritis	0.52% 1/191 • Number of events 1 All participants as treated population. Participants received rescue therapy if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue therapy. Other adverse events only include those AEs that occurred prior to a participant receiving rescue therapy.	0.00% 0/189 All participants as treated population. Participants received rescue therapy if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue therapy. Other adverse events only include those AEs that occurred prior to a participant receiving rescue therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/191 All participants as treated population. Participants received rescue therapy if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue therapy. Other adverse events only include those AEs that occurred prior to a participant receiving rescue therapy.	0.53% 1/189 • Number of events 1 All participants as treated population. Participants received rescue therapy if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue therapy. Other adverse events only include those AEs that occurred prior to a participant receiving rescue therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thymoma	0.52% 1/191 • Number of events 1 All participants as treated population. Participants received rescue therapy if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue therapy. Other adverse events only include those AEs that occurred prior to a participant receiving rescue therapy.	0.00% 0/189 All participants as treated population. Participants received rescue therapy if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue therapy. Other adverse events only include those AEs that occurred prior to a participant receiving rescue therapy.
Nervous system disorders Cerebral infarction	0.52% 1/191 • Number of events 1 All participants as treated population. Participants received rescue therapy if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue therapy. Other adverse events only include those AEs that occurred prior to a participant receiving rescue therapy.	0.00% 0/189 All participants as treated population. Participants received rescue therapy if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue therapy. Other adverse events only include those AEs that occurred prior to a participant receiving rescue therapy.
Nervous system disorders Transient ischaemic attack	0.52% 1/191 • Number of events 1 All participants as treated population. Participants received rescue therapy if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue therapy. Other adverse events only include those AEs that occurred prior to a participant receiving rescue therapy.	0.00% 0/189 All participants as treated population. Participants received rescue therapy if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue therapy. Other adverse events only include those AEs that occurred prior to a participant receiving rescue therapy.
Renal and urinary disorders Calculus urinary	0.52% 1/191 • Number of events 1 All participants as treated population. Participants received rescue therapy if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue therapy. Other adverse events only include those AEs that occurred prior to a participant receiving rescue therapy.	0.00% 0/189 All participants as treated population. Participants received rescue therapy if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue therapy. Other adverse events only include those AEs that occurred prior to a participant receiving rescue therapy.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.52% 1/191 • Number of events 1 All participants as treated population. Participants received rescue therapy if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue therapy. Other adverse events only include those AEs that occurred prior to a participant receiving rescue therapy.	0.00% 0/189 All participants as treated population. Participants received rescue therapy if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue therapy. Other adverse events only include those AEs that occurred prior to a participant receiving rescue therapy.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.52% 1/191 • Number of events 1 All participants as treated population. Participants received rescue therapy if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue therapy. Other adverse events only include those AEs that occurred prior to a participant receiving rescue therapy.	0.00% 0/189 All participants as treated population. Participants received rescue therapy if they met specific glycemic goals. Serious adverse events include events that occurred either before or after receiving rescue therapy. Other adverse events only include those AEs that occurred prior to a participant receiving rescue therapy.

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

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