Trial Outcomes & Findings for Study of the Durability of Glycemic Control With Nateglinide (NCT NCT00858013)

NCT ID: NCT00858013

Last Updated: 2017-05-16

Results Overview

% monotherapy failure, that means % number of participants who withdrew from the study due to high HbA1c (\>8.0%)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 88 participants
• Primary outcome timeframe: every 3 months following randomization, for 24 months
• Results posted on: 2017-05-16

Participant Flow

Participant milestones

Measure	Nateglinide Nateglinide 90\~120mg three times a day Nateglinide: Nateglinide 90\~120mg three times a day	Glimepiride Glimepiride 1\~2mg once a day Glimepiride: Glimepiride 1\~2mg once a day
Overall Study STARTED	46	42
Overall Study COMPLETED	24	23
Overall Study NOT COMPLETED	22	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of the Durability of Glycemic Control With Nateglinide

Baseline characteristics by cohort

Measure	Nateglinide n=46 Participants Nateglinide 90\~120mg three times a day Nateglinide: Nateglinide 90\~120mg three times a day	Glimepiride n=42 Participants Glimepiride 1\~2mg once a day Glimepiride: Glimepiride 1\~2mg once a day	Total n=88 Participants Total of all reporting groups
Age, Continuous	55.0 years STANDARD_DEVIATION 10.5 • n=5 Participants	55.1 years STANDARD_DEVIATION 12.3 • n=7 Participants	55 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	18 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants

PRIMARY outcome

Timeframe: every 3 months following randomization, for 24 months

% monotherapy failure, that means % number of participants who withdrew from the study due to high HbA1c (>8.0%)

Outcome measures

Measure	Nateglinide n=24 Participants Nateglinide 90\~120mg three times a day Nateglinide: Nateglinide 90\~120mg three times a day	Glimepiride n=23 Participants Glimepiride 1\~2mg once a day Glimepiride: Glimepiride 1\~2mg once a day
The Durability of Nateglinide in Comparison With Those of Glimepiride Based on the Withdrawal Rate	10 Participants	7 Participants

SECONDARY outcome

Timeframe: at 24 months

Population: data of participants who finished 24 months of follow-up

HbA1c (%) at 24 months

Outcome measures

Measure	Nateglinide n=14 Participants Nateglinide 90\~120mg three times a day Nateglinide: Nateglinide 90\~120mg three times a day	Glimepiride n=16 Participants Glimepiride 1\~2mg once a day Glimepiride: Glimepiride 1\~2mg once a day
HbA1c	6.9 % HbA1c Standard Deviation 0.6	6.5 % HbA1c Standard Deviation 0.5

SECONDARY outcome

Timeframe: at 24 months

Population: data of participants who finished 24 months of follow-up

fasting glucose (mg/dL) at 24 months

Outcome measures

Measure	Nateglinide n=14 Participants Nateglinide 90\~120mg three times a day Nateglinide: Nateglinide 90\~120mg three times a day	Glimepiride n=16 Participants Glimepiride 1\~2mg once a day Glimepiride: Glimepiride 1\~2mg once a day
Fasting Glucose	131.2 mg/dL Standard Deviation 25.9	115.7 mg/dL Standard Deviation 19.8

SECONDARY outcome

Timeframe: at 24 months

Population: data of participants who finished 24 months of follow-up

c-peptide(uU/mL) at 24 months

Outcome measures

Measure	Nateglinide n=14 Participants Nateglinide 90\~120mg three times a day Nateglinide: Nateglinide 90\~120mg three times a day	Glimepiride n=16 Participants Glimepiride 1\~2mg once a day Glimepiride: Glimepiride 1\~2mg once a day
C-peptide	1.29 uU/mL Standard Deviation 0.41	1.77 uU/mL Standard Deviation 0.72

SECONDARY outcome

Timeframe: at 24 months

Population: data of participants who finished 24 months of follow-up

insulin resistance marker HOMA-IR at 24 months

Outcome measures

Measure	Nateglinide n=14 Participants Nateglinide 90\~120mg three times a day Nateglinide: Nateglinide 90\~120mg three times a day	Glimepiride n=16 Participants Glimepiride 1\~2mg once a day Glimepiride: Glimepiride 1\~2mg once a day
HOMA-IR	2.40 mg/dL x mIU/L Standard Deviation 1.36	2.31 mg/dL x mIU/L Standard Deviation 1.70

Adverse Events

Nateglinide

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Glimepiride

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Nateglinide n=24 participants at risk Nateglinide 90\~120mg three times a day Nateglinide: Nateglinide 90\~120mg three times a day	Glimepiride n=23 participants at risk Glimepiride 1\~2mg once a day Glimepiride: Glimepiride 1\~2mg once a day
Endocrine disorders hypoglycemia	4.2% 1/24 • 6 months	0.00% 0/23 • 6 months
Gastrointestinal disorders dyspepsia	8.3% 2/24 • 6 months	0.00% 0/23 • 6 months
Gastrointestinal disorders gall stone	4.2% 1/24 • 6 months	0.00% 0/23 • 6 months
Skin and subcutaneous tissue disorders herpes zoster	4.2% 1/24 • 6 months	0.00% 0/23 • 6 months
Gastrointestinal disorders gastritis	4.2% 1/24 • 6 months	0.00% 0/23 • 6 months
Nervous system disorders dizziness	0.00% 0/24 • 6 months	4.3% 1/23 • 6 months

Additional Information

Kwan Woo Lee

Ajou University

Phone: 82-31-219-4526

Email: lkw65@ajou.ac.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place