Trial Outcomes & Findings for An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (MK0431-023) (NCT NCT00094757)

Last Updated: 2019-05-30

Results Overview

Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

521 participants

Primary outcome timeframe

Weeks 0-18

Results posted on

2019-05-30

Participant Flow

First Patient In: 15-Oct-2004. Last Patient Last Visit: 28-Apr-2006. 60 medical clinics in the United States (US), 37 in 4 countries in Europe, and 17 in 5 countries in the rest of the world.

Patients 18-75 years of age with type 2 diabetes mellitus (T2DM) with inadequate glycemic control (Hemoglobin A1C ≥7% and ≤10.0%) on diet and exercise alone were eligible to enter the study.

Participant milestones

Participant milestones
Measure	Sitagliptin 100 mg The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.	Sitagliptin 200 mg The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.	Placebo/Pioglitazone The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
Overall Study STARTED	205	206	110
Overall Study COMPLETED	152	144	80
Overall Study NOT COMPLETED	53	62	30

Reasons for withdrawal

Reasons for withdrawal
Measure	Sitagliptin 100 mg The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.	Sitagliptin 200 mg The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.	Placebo/Pioglitazone The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
Overall Study Adverse Event	11	9	6
Overall Study Lack of Efficacy	11	15	8
Overall Study Lost to Follow-up	3	5	6
Overall Study Patient Moved	2	1	1
Overall Study Protocol Violation	8	5	3
Overall Study Withdrawal by Subject	14	21	5
Overall Study Other	3	3	1
Overall Study Protocol specified discontinuation	1	3	0

Baseline Characteristics

An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (MK0431-023)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sitagliptin 100 mg n=205 Participants The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.	Sitagliptin 200 mg n=206 Participants The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.	Placebo/Pioglitazone n=110 Participants The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.	Total n=521 Participants Total of all reporting groups
Age, Continuous	54.5 years STANDARD_DEVIATION 10.0 • n=93 Participants	55.4 years STANDARD_DEVIATION 9.2 • n=4 Participants	55.5 years STANDARD_DEVIATION 10.1 • n=27 Participants	55.1 years STANDARD_DEVIATION 9.7 • n=483 Participants
Sex: Female, Male Female	95 Participants n=93 Participants	102 Participants n=4 Participants	41 Participants n=27 Participants	238 Participants n=483 Participants
Sex: Female, Male Male	110 Participants n=93 Participants	104 Participants n=4 Participants	69 Participants n=27 Participants	283 Participants n=483 Participants
Race/Ethnicity, Customized White	142 participants n=93 Participants	146 participants n=4 Participants	68 participants n=27 Participants	356 participants n=483 Participants
Race/Ethnicity, Customized Black	16 participants n=93 Participants	11 participants n=4 Participants	12 participants n=27 Participants	39 participants n=483 Participants
Race/Ethnicity, Customized Hispanic	37 participants n=93 Participants	39 participants n=4 Participants	22 participants n=27 Participants	98 participants n=483 Participants
Race/Ethnicity, Customized Asian	8 participants n=93 Participants	7 participants n=4 Participants	5 participants n=27 Participants	20 participants n=483 Participants
Race/Ethnicity, Customized Other	2 participants n=93 Participants	3 participants n=4 Participants	3 participants n=27 Participants	8 participants n=483 Participants
Hemoglobin A1C (A1C)	8.0 Percent STANDARD_DEVIATION 0.8 • n=93 Participants	8.1 Percent STANDARD_DEVIATION 0.9 • n=4 Participants	8.0 Percent STANDARD_DEVIATION 0.9 • n=27 Participants	8.1 Percent STANDARD_DEVIATION 0.9 • n=483 Participants

PRIMARY outcome

Timeframe: Weeks 0-18

Population: All Patients Treated included those with ≥1 dose of study therapy, had a baseline and ≥1 post-baseline value. For those with no data at Week 18, last post-baseline observation was carried forward. Data after initiation of glycemic rescue were considered missing. Analysis adjusted for baseline values and prior antihyperglycemic therapy status.

Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.

Outcome measures

Outcome measures
Measure	Sitagliptin 100 mg n=193 Participants The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.	Sitagliptin 200 mg n=199 Participants The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.	Placebo/Pioglitazone n=103 Participants The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
Change From Baseline in A1C at Week 18	-0.48 percent Interval -0.61 to -0.35	-0.36 percent Interval -0.48 to -0.23	0.12 percent Interval -0.05 to 0.3

SECONDARY outcome

Timeframe: Weeks 0-18

Population: All Patients Treated included patients who received at least 1 dose of study therapy, and had a baseline value and ≥1 post-baseline value for this outcome. The last post-baseline observed measurement was carried forward to Week 18 for patients with no data at Week 18. Data after initiation of glycemic rescue were considered missing.

The change from baseline reflects the Week 18 Fasting Plasma Glucose (FPG) minus the Week 0 FPG.

Outcome measures

Outcome measures
Measure	Sitagliptin 100 mg n=201 Participants The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.	Sitagliptin 200 mg n=202 Participants The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.	Placebo/Pioglitazone n=107 Participants The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
Change From Baseline in FPG at Week 18	-12.7 mg/dL Interval -19.1 to -6.3	-9.9 mg/dL Interval -16.2 to -3.5	7.0 mg/dL Interval -1.8 to 15.8

SECONDARY outcome

Timeframe: Weeks 0-54

Population: All Patients Treated included patients who received at least 1 dose of study therapy post-Week 18, a baseline value and ≥1 post-Week 18 value for this outcome. The last post- Week 18 observed measurement was carried forward to Week 54 for patients with no data at Week 54. Data after initiation of glycemic rescue were considered missing.

A1C is measured as percent. Thus this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent.

Outcome measures

Outcome measures
Measure	Sitagliptin 100 mg n=156 Participants The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.	Sitagliptin 200 mg n=158 Participants The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.	Placebo/Pioglitazone n=68 Participants The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
Change From Baseline in A1C at Week 54	-0.28 percent Interval -0.42 to -0.14	-0.19 percent Interval -0.33 to -0.05	-0.87 percent Interval -1.08 to -0.66

SECONDARY outcome

Timeframe: Weeks 0-54

Population: All Patients Treated included patients who received at least 1 dose of study therapy 1 post-Week 18, a baseline value and ≥1 post-Week 18 value for this outcome. The last post- Week 18 observed measurement was carried forward to Week 54 for patients with no data at Week 54. Data after initiation of glycemic rescue were considered missing.

The change from baseline reflects the Week 54 FPG minus the Week 0 FPG.

Outcome measures

Outcome measures
Measure	Sitagliptin 100 mg n=159 Participants The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.	Sitagliptin 200 mg n=160 Participants The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.	Placebo/Pioglitazone n=70 Participants The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
Change From Baseline in FPG at Week 54	-5.5 mg/dL Interval -11.5 to 0.5	-0.7 mg/dL Interval -6.7 to 5.3	-28.0 mg/dL Interval -37.1 to -18.9

Adverse Events

Sitagliptin 100 mg

Serious events: 15 serious events

Other events: 70 other events

Deaths: 0 deaths

Sitagliptin 200 mg

Serious events: 12 serious events

Other events: 55 other events

Deaths: 0 deaths

Placebo/Pioglitazone

Serious events: 10 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Sitagliptin 100 mg n=205 participants at risk The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.	Sitagliptin 200 mg n=206 participants at risk The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.	Placebo/Pioglitazone n=110 participants at risk The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
Infections and infestations Influenza	5.4% 11/205 • Weeks 0 to 54 Patients received rescue medication if they met specific glycemic goals. SAEs include events that occurred either before or after receiving rescue medication. Other AEs only includes those AEs that occurred prior to a patient receiving rescue medication.	3.9% 8/206 • Weeks 0 to 54 Patients received rescue medication if they met specific glycemic goals. SAEs include events that occurred either before or after receiving rescue medication. Other AEs only includes those AEs that occurred prior to a patient receiving rescue medication.	6.4% 7/110 • Weeks 0 to 54 Patients received rescue medication if they met specific glycemic goals. SAEs include events that occurred either before or after receiving rescue medication. Other AEs only includes those AEs that occurred prior to a patient receiving rescue medication.
Infections and infestations Upper Respiratory Tract Infection	4.4% 9/205 • Weeks 0 to 54 Patients received rescue medication if they met specific glycemic goals. SAEs include events that occurred either before or after receiving rescue medication. Other AEs only includes those AEs that occurred prior to a patient receiving rescue medication.	6.8% 14/206 • Weeks 0 to 54 Patients received rescue medication if they met specific glycemic goals. SAEs include events that occurred either before or after receiving rescue medication. Other AEs only includes those AEs that occurred prior to a patient receiving rescue medication.	5.5% 6/110 • Weeks 0 to 54 Patients received rescue medication if they met specific glycemic goals. SAEs include events that occurred either before or after receiving rescue medication. Other AEs only includes those AEs that occurred prior to a patient receiving rescue medication.
Infections and infestations Urinary Tract Infection	3.9% 8/205 • Weeks 0 to 54 Patients received rescue medication if they met specific glycemic goals. SAEs include events that occurred either before or after receiving rescue medication. Other AEs only includes those AEs that occurred prior to a patient receiving rescue medication.	4.9% 10/206 • Weeks 0 to 54 Patients received rescue medication if they met specific glycemic goals. SAEs include events that occurred either before or after receiving rescue medication. Other AEs only includes those AEs that occurred prior to a patient receiving rescue medication.	8.2% 9/110 • Weeks 0 to 54 Patients received rescue medication if they met specific glycemic goals. SAEs include events that occurred either before or after receiving rescue medication. Other AEs only includes those AEs that occurred prior to a patient receiving rescue medication.
Investigations Blood Glucose Increased	8.3% 17/205 • Weeks 0 to 54 Patients received rescue medication if they met specific glycemic goals. SAEs include events that occurred either before or after receiving rescue medication. Other AEs only includes those AEs that occurred prior to a patient receiving rescue medication.	3.4% 7/206 • Weeks 0 to 54 Patients received rescue medication if they met specific glycemic goals. SAEs include events that occurred either before or after receiving rescue medication. Other AEs only includes those AEs that occurred prior to a patient receiving rescue medication.	8.2% 9/110 • Weeks 0 to 54 Patients received rescue medication if they met specific glycemic goals. SAEs include events that occurred either before or after receiving rescue medication. Other AEs only includes those AEs that occurred prior to a patient receiving rescue medication.
Investigations Glycosylated Haemoglobin Increased	5.4% 11/205 • Weeks 0 to 54 Patients received rescue medication if they met specific glycemic goals. SAEs include events that occurred either before or after receiving rescue medication. Other AEs only includes those AEs that occurred prior to a patient receiving rescue medication.	0.97% 2/206 • Weeks 0 to 54 Patients received rescue medication if they met specific glycemic goals. SAEs include events that occurred either before or after receiving rescue medication. Other AEs only includes those AEs that occurred prior to a patient receiving rescue medication.	2.7% 3/110 • Weeks 0 to 54 Patients received rescue medication if they met specific glycemic goals. SAEs include events that occurred either before or after receiving rescue medication. Other AEs only includes those AEs that occurred prior to a patient receiving rescue medication.
Musculoskeletal and connective tissue disorders Arthralgia	2.4% 5/205 • Weeks 0 to 54 Patients received rescue medication if they met specific glycemic goals. SAEs include events that occurred either before or after receiving rescue medication. Other AEs only includes those AEs that occurred prior to a patient receiving rescue medication.	4.4% 9/206 • Weeks 0 to 54 Patients received rescue medication if they met specific glycemic goals. SAEs include events that occurred either before or after receiving rescue medication. Other AEs only includes those AEs that occurred prior to a patient receiving rescue medication.	5.5% 6/110 • Weeks 0 to 54 Patients received rescue medication if they met specific glycemic goals. SAEs include events that occurred either before or after receiving rescue medication. Other AEs only includes those AEs that occurred prior to a patient receiving rescue medication.
Musculoskeletal and connective tissue disorders Back Pain	6.8% 14/205 • Weeks 0 to 54 Patients received rescue medication if they met specific glycemic goals. SAEs include events that occurred either before or after receiving rescue medication. Other AEs only includes those AEs that occurred prior to a patient receiving rescue medication.	5.3% 11/206 • Weeks 0 to 54 Patients received rescue medication if they met specific glycemic goals. SAEs include events that occurred either before or after receiving rescue medication. Other AEs only includes those AEs that occurred prior to a patient receiving rescue medication.	4.5% 5/110 • Weeks 0 to 54 Patients received rescue medication if they met specific glycemic goals. SAEs include events that occurred either before or after receiving rescue medication. Other AEs only includes those AEs that occurred prior to a patient receiving rescue medication.
Nervous system disorders Headache	6.3% 13/205 • Weeks 0 to 54 Patients received rescue medication if they met specific glycemic goals. SAEs include events that occurred either before or after receiving rescue medication. Other AEs only includes those AEs that occurred prior to a patient receiving rescue medication.	5.3% 11/206 • Weeks 0 to 54 Patients received rescue medication if they met specific glycemic goals. SAEs include events that occurred either before or after receiving rescue medication. Other AEs only includes those AEs that occurred prior to a patient receiving rescue medication.	4.5% 5/110 • Weeks 0 to 54 Patients received rescue medication if they met specific glycemic goals. SAEs include events that occurred either before or after receiving rescue medication. Other AEs only includes those AEs that occurred prior to a patient receiving rescue medication.

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 Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER