Trial Outcomes & Findings for An Open Study to Evaluate Whether Pack Size Affects Compliance of Metformin Treatment in Subjects With Type II Diabetes (NCT NCT01817777)

Results Overview

HbA1c was tested with a point-of-care device, which required a finger prick to obtain blood and provided an immediate result upon analysis in the device. HbA1c was tested at pharmacy visits corresponding to three time points: enrollment (Week 0), Baseline (Week 8), and End of Study (Week 28). The difference in the mean change from Baseline was to be calculated between the treatment arms (small pack minus large pack), and the 2-sided 95% confidence interval for the difference in mean change in HbA1c was to be calculated. However, because the study was terminated early, and the sample size was reduced, the statistical hypotheses defined in the protocol were not tested due to insufficient power. Therefore, the final analyses were limited to descriptive statistics. The percentage HbA1c is a measure of how much of the hemoglobin in the blood has become glycated (chemically bounded to glucose).

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

31 participants

Primary outcome timeframe

Baseline (Week 8) and Week 28

Results posted on

2017-01-09

Participant Flow

Participants aged \>=18 years with a diagnosis of Type II diabetes mellitus (T2DM) and a glycated hemoglobin (HbA1c) value no higher than 9.0%; with evidence of a physician-supplied prescription for metformin use and on a stable dose of metformin for 3 months prior to enrollment; and on no anti-diabetic medication other than metformin were enrolled.

Enrolled participants entered an 8-week Observational Phase (OP) prior to randomization to one of the treatment arms, followed by a 20-week Interventional Phase (IP). A total of 288 participants were planned; however, the study was prematurely discontinued when 36 participants had entered the OP. Of these 36, 31 had entered the IP.

Participant milestones

Participant milestones
Measure	Routine Metformin Participants were followed during an 8-week Observational Phase. During this phase, participants visited the pharmacy and purchased metformin (MTF) as per their usual routines.	Small Pack Metformin Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).	Large Pack Metformin Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month's supply of metformin.
Observational Phase (8 Weeks) STARTED	36	0	0
Observational Phase (8 Weeks) COMPLETED	31	0	0
Observational Phase (8 Weeks) NOT COMPLETED	5	0	0
Interventional Phase (20 Weeks) STARTED	0	16	15
Interventional Phase (20 Weeks) COMPLETED	0	11	10
Interventional Phase (20 Weeks) NOT COMPLETED	0	5	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Routine Metformin Participants were followed during an 8-week Observational Phase. During this phase, participants visited the pharmacy and purchased metformin (MTF) as per their usual routines.	Small Pack Metformin Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).	Large Pack Metformin Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month's supply of metformin.
Observational Phase (8 Weeks) Lost to Follow-up	3	0	0
Observational Phase (8 Weeks) Early Study Termination	2	0	0
Interventional Phase (20 Weeks) Withdrawal by Subject	0	3	0
Interventional Phase (20 Weeks) Lost to Follow-up	0	1	2
Interventional Phase (20 Weeks) Early Study Termination	0	1	3

Baseline Characteristics

An Open Study to Evaluate Whether Pack Size Affects Compliance of Metformin Treatment in Subjects With Type II Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Small Pack Metformin n=16 Participants Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).	Large Pack Metformin n=15 Participants Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month's supply of metformin.	Total n=31 Participants Total of all reporting groups
Age, Continuous	58.3 Years STANDARD_DEVIATION 12.01 • n=5 Participants	56.3 Years STANDARD_DEVIATION 10.52 • n=7 Participants	57.3 Years STANDARD_DEVIATION 11.17 • n=5 Participants
Gender Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Gender Male	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Caucasic (White)	16 participants n=5 Participants	15 participants n=7 Participants	31 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Week 8) and Week 28

Population: Per Protocol Population: all participants in the Intent-to-Treat Population (randomly assigned to treatment and who received \>= 1 dose \[or any portion of a dose\] of study medication and had an HbA1c test at Week 8) who did not have a protocol violation

HbA1c was tested with a point-of-care device, which required a finger prick to obtain blood and provided an immediate result upon analysis in the device. HbA1c was tested at pharmacy visits corresponding to three time points: enrollment (Week 0), Baseline (Week 8), and End of Study (Week 28). The difference in the mean change from Baseline was to be calculated between the treatment arms (small pack minus large pack), and the 2-sided 95% confidence interval for the difference in mean change in HbA1c was to be calculated. However, because the study was terminated early, and the sample size was reduced, the statistical hypotheses defined in the protocol were not tested due to insufficient power. Therefore, the final analyses were limited to descriptive statistics. The percentage HbA1c is a measure of how much of the hemoglobin in the blood has become glycated (chemically bounded to glucose).