Trial Outcomes & Findings for Sulfonylurea Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-035) (NCT NCT00106704)

Last Updated: 2015-07-01

Results Overview

Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

441 participants

Primary outcome timeframe

Baseline and 24 Weeks

Results posted on

2015-07-01

Participant Flow

First Patient In: 27-Apr-2005. Last Patient Last Visit: 09-Jan-2007. 27 medical clinics in the United States (US), 25 in 11 countries in Europe, and 22 in 11 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 \[A1C\] ≥7.5% and ≤10.5%) at screening or after treatment with glimepiride (≥4 mg) alone or in combination with metformin (≥1500 mg) for a dose stable period of up to 10 weeks were eligible to participate.

Participant milestones

Participant milestones
Measure	Sitagliptin The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).	Placebo/ Pioglitazone The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
Overall Study STARTED	222	219
Overall Study COMPLETED	91	68
Overall Study NOT COMPLETED	131	151

Reasons for withdrawal

Reasons for withdrawal
Measure	Sitagliptin The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).	Placebo/ Pioglitazone The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
Overall Study Adverse Event	10	7
Overall Study Death	2	1
Overall Study Lack of Efficacy	67	69
Overall Study Lost to Follow-up	7	3
Overall Study Pregnancy	1	0
Overall Study Protocol Violation	4	7
Overall Study Withdrawal by Subject	14	21
Overall Study Patient moved	1	0
Overall Study Site terminated	0	1
Overall Study Planned major surgery	1	0
Overall Study Patient Received Glycemic Medication	22	41
Overall Study Unable to re-enter US	1	0
Overall Study Laboratory test	1	1

Baseline Characteristics

Sulfonylurea Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-035)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sitagliptin n=222 Participants The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).	Placebo/ Pioglitazone n=219 Participants The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).	Total n=441 Participants Total of all reporting groups
Age, Continuous	55.6 years STANDARD_DEVIATION 9.6 • n=5 Participants	56.5 years STANDARD_DEVIATION 9.6 • n=7 Participants	56.0 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	105 Participants n=5 Participants	102 Participants n=7 Participants	207 Participants n=5 Participants
Sex: Female, Male Male	117 Participants n=5 Participants	117 Participants n=7 Participants	234 Participants n=5 Participants
Race/Ethnicity, Customized White	136 participants n=5 Participants	140 participants n=7 Participants	276 participants n=5 Participants
Race/Ethnicity, Customized Black	10 participants n=5 Participants	12 participants n=7 Participants	22 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	39 participants n=5 Participants	32 participants n=7 Participants	71 participants n=5 Participants
Race/Ethnicity, Customized Asian	22 participants n=5 Participants	25 participants n=7 Participants	47 participants n=5 Participants
Race/Ethnicity, Customized Other	15 participants n=5 Participants	10 participants n=7 Participants	25 participants n=5 Participants
Fasting Plasma Glucose (FPG)	180.9 mg/dL STANDARD_DEVIATION 37.7 • n=5 Participants	181.6 mg/dL STANDARD_DEVIATION 42.5 • n=7 Participants	181.2 mg/dL STANDARD_DEVIATION 40.1 • n=5 Participants
Hemoglobin A1C (A1C)	8.34 Percent STANDARD_DEVIATION 0.76 • n=5 Participants	8.34 Percent STANDARD_DEVIATION 0.74 • n=7 Participants	8.34 Percent STANDARD_DEVIATION 0.75 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 24 Weeks

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 24 for patients with no data at Week 24. Data obtained after glycemic rescue were considered missing.

Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.

Outcome measures

Outcome measures
Measure	Sitagliptin n=217 Participants The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).	Placebo/ Pioglitazone n=208 Participants The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
Change From Baseline in A1C at Week 24	-0.45 Percent Interval -0.57 to -0.34	0.28 Percent Interval 0.17 to 0.4

SECONDARY outcome

Timeframe: Baseline and 24 Weeks

The change from baseline is the Week 24 Fasting Plasma Glucose (FPG) minus the Week 0 FPG.

Outcome measures

Outcome measures
Measure	Sitagliptin n=219 Participants The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).	Placebo/ Pioglitazone n=213 Participants The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
Change From Baseline in FPG at Week 24	-4.4 mg/dL Interval -10.2 to 1.4	15.7 mg/dL Interval 9.8 to 21.6

Adverse Events

Sitagliptin

Serious events: 17 serious events

Other events: 66 other events

Deaths: 0 deaths

Placebo/ Pioglitazone

Serious events: 13 serious events

Other events: 57 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Sitagliptin n=222 participants at risk The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).	Placebo/ Pioglitazone n=219 participants at risk The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
Infections and infestations Nasopharyngitis	8.6% 19/222 • Weeks 0 to 54 Patients received glycemic rescue medication if they met specific glycemic goals. SAEs includes 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% 12/219 • Weeks 0 to 54 Patients received glycemic rescue medication if they met specific glycemic goals. SAEs includes 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	7.7% 17/222 • Weeks 0 to 54 Patients received glycemic rescue medication if they met specific glycemic goals. SAEs includes 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.	9.1% 20/219 • Weeks 0 to 54 Patients received glycemic rescue medication if they met specific glycemic goals. SAEs includes 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	5.4% 12/222 • Weeks 0 to 54 Patients received glycemic rescue medication if they met specific glycemic goals. SAEs includes 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% 6/219 • Weeks 0 to 54 Patients received glycemic rescue medication if they met specific glycemic goals. SAEs includes 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	2.7% 6/222 • Weeks 0 to 54 Patients received glycemic rescue medication if they met specific glycemic goals. SAEs includes 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.	5.0% 11/219 • Weeks 0 to 54 Patients received glycemic rescue medication if they met specific glycemic goals. SAEs includes 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.
Metabolism and nutrition disorders Hypoglycaemia	13.5% 30/222 • Weeks 0 to 54 Patients received glycemic rescue medication if they met specific glycemic goals. SAEs includes 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.	5.9% 13/219 • Weeks 0 to 54 Patients received glycemic rescue medication if they met specific glycemic goals. SAEs includes 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% 14/222 • Weeks 0 to 54 Patients received glycemic rescue medication if they met specific glycemic goals. SAEs includes 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.	2.3% 5/219 • Weeks 0 to 54 Patients received glycemic rescue medication if they met specific glycemic goals. SAEs includes 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