Trial Outcomes & Findings for Response To Oral Agents in Diabetes (ROAD)- Pilot Study (NCT NCT00780715)

Results Overview

Units are absolute difference in %HbA1c (HbA1c being the percentage of glycated Haemoglobin, reflecting glucose exposure over the last 3 months)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

29 participants

Primary outcome timeframe

6 months

Results posted on

2017-10-26

Participant Flow

Participant milestones

Participant milestones
Measure	Gliclazide MR Gliclazide MR: 30mg daily increased to 60mg if HbA1c \> 7% at 3 months	Sitagliptin Sitagliptin: Sitagliptin 100mg daily for 6 months	Pioglitazone Pioglitazone: Pioglitazone 30mg daily , increased to 45mg daily if HbA1c \>7% at 3 months. 6 months duration	Metformin Metformin: Metformin 500 mg od for 1 week, bd for 1 week, 1g mane 500 mg nocte 1 week, 1g bd there after. Total of 6 months treatment
Overall Study STARTED	6	6	6	11
Overall Study COMPLETED	6	6	6	11
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Response To Oral Agents in Diabetes (ROAD)- Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gliclazide MR n=6 Participants Gliclazide MR: 30mg daily increased to 60mg if HbA1c \> 7% at 3 months	Sitagliptin n=6 Participants Sitagliptin: Sitagliptin 100mg daily for 6 months	Pioglitazone n=6 Participants Pioglitazone: Pioglitazone 30mg daily , increased to 45mg daily if HbA1c \>7% at 3 months. 6 months duration	Metformin n=11 Participants Metformin: Metformin 500 mg od for 1 week, bd for 1 week, 1g mane 500 mg nocte 1 week, 1g bd there after. Total of 6 months treatment	Total n=29 Participants Total of all reporting groups
Age, Continuous	62.4 years STANDARD_DEVIATION 4.6 • n=5 Participants	61.5 years STANDARD_DEVIATION 9.9 • n=7 Participants	61.3 years STANDARD_DEVIATION 11.8 • n=5 Participants	59.6 years STANDARD_DEVIATION 8.8 • n=4 Participants	60.9 years STANDARD_DEVIATION 9.2 • n=21 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants	14 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	15 Participants n=21 Participants
Region of Enrollment United Kingdom	6 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	11 Participants n=4 Participants	29 Participants n=21 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Modified Intention to treat

Units are absolute difference in %HbA1c (HbA1c being the percentage of glycated Haemoglobin, reflecting glucose exposure over the last 3 months)

Outcome measures

Outcome measures
Measure	Gliclazide MR n=5 Participants Gliclazide MR: 30mg daily increased to 60mg if HbA1c \> 7% at 3 months	Sitagliptin n=5 Participants Sitagliptin: Sitagliptin 100mg daily for 6 months	Pioglitazone n=5 Participants Pioglitazone: Pioglitazone 30mg daily , increased to 45mg daily if HbA1c \>7% at 3 months. 6 months duration	Metformin n=8 Participants Metformin: Metformin 500 mg od for 1 week, bd for 1 week, 1g mane 500 mg nocte 1 week, 1g bd there after. Total of 6 months treatment
HbA1c Change	-0.42 absolute change in %HbA1c Standard Deviation 0.72	-0.58 absolute change in %HbA1c Standard Deviation 0.63	-1.04 absolute change in %HbA1c Standard Deviation 0.71	-1.59 absolute change in %HbA1c Standard Deviation 0.60

Adverse Events

Gliclazide MR

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sitagliptin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pioglitazone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Metformin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Ewan Pearson

University of Dundee

Phone: +44 (0) 1382 383387

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place