Trial Outcomes & Findings for Evaluation of Continuous Glucose Monitoring in Participants With Type 2 Diabetes Mellitus (MK-0000-258 AM2) (NCT NCT01537120)
NCT ID: NCT01537120
Last Updated: 2015-08-19
Results Overview
The 24 hour WMG was measured after 2 weeks of placebo treatment, and again after 2 weeks of vildagliptin treatment. Glucose was measured over a 24 hour period by having participants wear two continuous glucose monitors (CGM), which produced an average glucose value approximately every 5 minutes. Using these values, the concentration of glucose was calculated from Area Under the Curve 0-24 hours (AUC 0-24hr), and was expressed as 24 hour WMG.
COMPLETED
PHASE1
25 participants
At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment
2015-08-19
Participant Flow
After enrollment, participants previously treated with both metformin and sulfonylurea, discontinued sulfonylurea usage and underwent washout of sulfonylurea over a period of 8 weeks prior to treatment. Non-washout participants were enrolled on a clinical regimen of metformin alone.
Participant milestones
| Measure |
Placebo → Vildagliptin
Participants received placebo tablets orally, twice a day for 3 weeks, and then over the next 12 weeks received vildagliptin 50 mg tablets orally, twice daily
|
|---|---|
|
Enrolled
STARTED
|
25
|
|
Enrolled
COMPLETED
|
25
|
|
Enrolled
NOT COMPLETED
|
0
|
|
8 Weeks Washout
STARTED
|
25
|
|
8 Weeks Washout
COMPLETED
|
24
|
|
8 Weeks Washout
NOT COMPLETED
|
1
|
|
3 Weeks Placebo
STARTED
|
24
|
|
3 Weeks Placebo
COMPLETED
|
23
|
|
3 Weeks Placebo
NOT COMPLETED
|
1
|
|
12 Weeks Vildagliptin
STARTED
|
23
|
|
12 Weeks Vildagliptin
COMPLETED
|
23
|
|
12 Weeks Vildagliptin
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Placebo → Vildagliptin
Participants received placebo tablets orally, twice a day for 3 weeks, and then over the next 12 weeks received vildagliptin 50 mg tablets orally, twice daily
|
|---|---|
|
8 Weeks Washout
Inclusion/exclusion criteria not met
|
1
|
|
3 Weeks Placebo
Withdrawal by Subject
|
1
|
Baseline Characteristics
Evaluation of Continuous Glucose Monitoring in Participants With Type 2 Diabetes Mellitus (MK-0000-258 AM2)
Baseline characteristics by cohort
| Measure |
Placebo → Vildagliptin
n=25 Participants
Participants received placebo tablets orally, twice a day for 3 weeks, and then over the next 12 weeks received vildagliptin 50 mg tablets orally, twice daily
|
|---|---|
|
Age, Continuous
|
62 Years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatmentPopulation: Per-Protocol Population: all participants who complied with the assigned medication during each period of study.
The 24 hour WMG was measured after 2 weeks of placebo treatment, and again after 2 weeks of vildagliptin treatment. Glucose was measured over a 24 hour period by having participants wear two continuous glucose monitors (CGM), which produced an average glucose value approximately every 5 minutes. Using these values, the concentration of glucose was calculated from Area Under the Curve 0-24 hours (AUC 0-24hr), and was expressed as 24 hour WMG.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo tablets twice daily for 3 weeks
|
Vildagliptin
n=23 Participants
Vildagliptin tablets 50 mg twice daily for 12 weeks
|
|---|---|---|
|
24 Hour Weighted Mean Glucose (WMG) At 2 Weeks
|
126.9 mg/dL
Geometric Coefficient of Variation 16
|
114.2 mg/dL
Geometric Coefficient of Variation 17
|
SECONDARY outcome
Timeframe: At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatmentPopulation: Per-Protocol Population: all participants who complied with the assigned medication during each period of study.
Blood samples were taken after 2 weeks of placebo treatment, and again after 2 weeks of vildagliptin treatment to measure the percentage of glycated hemoglobin, HbA1C. Units are therefore presented as HbA1c (%).
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo tablets twice daily for 3 weeks
|
Vildagliptin
n=23 Participants
Vildagliptin tablets 50 mg twice daily for 12 weeks
|
|---|---|---|
|
Hemoglobin A1C (HbA1C) At 2 Weeks
|
7.12 HbA1c (%)
Standard Deviation 0.54
|
6.82 HbA1c (%)
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: At 2 weeks after Placebo treatment and again at 12 weeks after Vildagliptin treatmentPopulation: Per-Protocol Population: all participants who complied with the assigned medication during each period of study.
Blood samples were taken after 2 weeks of placebo treatment, and again after 12 weeks of vildagliptin treatment to measure the percentage of glycated hemoglobin, HbA1C. Units are therefore presented as HbA1c (%).
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo tablets twice daily for 3 weeks
|
Vildagliptin
n=23 Participants
Vildagliptin tablets 50 mg twice daily for 12 weeks
|
|---|---|---|
|
HbA1C At 12 Weeks
|
7.12 HbA1c (%)
Standard Deviation 0.54
|
6.66 HbA1c (%)
Standard Deviation 0.74
|
Adverse Events
Vildagliptin 50 mg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vildagliptin 50 mg
n=23 participants at risk
Vildagliptin tablets 50 mg twice daily for 12 weeks
|
Placebo
n=24 participants at risk
Placebo tablets twice daily for 3 weeks
|
|---|---|---|
|
General disorders
Reaction CGM Site
|
8.7%
2/23 • Number of events 2
|
8.3%
2/24 • Number of events 2
|
|
General disorders
Reaction site cannula
|
13.0%
3/23 • Number of events 4
|
20.8%
5/24 • Number of events 5
|
|
General disorders
Tiredness
|
13.0%
3/23 • Number of events 3
|
0.00%
0/24
|
|
Infections and infestations
Upper respiratory tract infection
|
17.4%
4/23 • Number of events 4
|
16.7%
4/24 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
8.7%
2/23 • Number of events 2
|
0.00%
0/24
|
|
Gastrointestinal disorders
Vomiting
|
8.7%
2/23 • Number of events 2
|
0.00%
0/24
|
|
Nervous system disorders
Dizziness
|
8.7%
2/23 • Number of events 2
|
8.3%
2/24 • Number of events 2
|
|
Nervous system disorders
Headache
|
17.4%
4/23 • Number of events 4
|
16.7%
4/24 • Number of events 5
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER