Trial Outcomes & Findings for EQW, DAPA, EQW/DAPA, DAPA/MET ER and PHEN/TPM ER in Obese Women With PolycysticOvary Syndrome (PCOS) (NCT NCT02635386)
NCT ID: NCT02635386
Last Updated: 2021-01-29
Results Overview
An estimation of β-cell compensatory function, the insulin secretion-sensitivity index (IS-SI) will be derived by applying the concept of the oral disposition index to measurements obtained during the 2-h OGTT and calculated as the index of insulin secretion factored by insulin sensitivity (ΔINS/ΔPG 30 x Matsuda SIOGTT) from the OGTT. A higher score shows improved pancreatic insulin responsiveness relative to resistance.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
119 participants
Primary outcome timeframe
24 weeks of treatment
Results posted on
2021-01-29
Participant Flow
130 consented and 11 did not meet criteria and not randomized
Participant milestones
| Measure |
Exenatide Once Weekly (EQW )
EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks
Exenatide once weekly (EQW ): 2 mg SC injection every 7 days
|
Dapagliflozin (DAPA)
DAPA-10 mg oral pill once daily in am for 24 weeks
Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am
|
EQW Plus DAPA
EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks
EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am
|
Dapagliflozin Plus Glucophage (MET ER)
Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks
Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose
|
Phentermine /Topiramate (PHEN/ TRP) ER
Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks
Phentermine /Topiramate (PHEN/ TRP) ER: PHEN 3.75/TRP ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TRP ER 46mg- 1 pill by mouth once daily in am
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
22
|
26
|
25
|
|
Overall Study
COMPLETED
|
20
|
17
|
20
|
19
|
16
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
2
|
7
|
9
|
Reasons for withdrawal
| Measure |
Exenatide Once Weekly (EQW )
EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks
Exenatide once weekly (EQW ): 2 mg SC injection every 7 days
|
Dapagliflozin (DAPA)
DAPA-10 mg oral pill once daily in am for 24 weeks
Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am
|
EQW Plus DAPA
EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks
EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am
|
Dapagliflozin Plus Glucophage (MET ER)
Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks
Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose
|
Phentermine /Topiramate (PHEN/ TRP) ER
Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks
Phentermine /Topiramate (PHEN/ TRP) ER: PHEN 3.75/TRP ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TRP ER 46mg- 1 pill by mouth once daily in am
|
|---|---|---|---|---|---|
|
Overall Study
Pregnancy
|
2
|
0
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Moved Out of State
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Noncompliant
|
0
|
2
|
1
|
1
|
1
|
|
Overall Study
side effects
|
0
|
0
|
1
|
4
|
6
|
|
Overall Study
needed other major surgery
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Other medical problems not drug related
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
EQW, DAPA, EQW/DAPA, DAPA/MET ER and PHEN/TPM ER in Obese Women With PolycysticOvary Syndrome (PCOS)
Baseline characteristics by cohort
| Measure |
Exenatide Once Weekly (EQW )
n=23 Participants
EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks
Exenatide once weekly (EQW ): 2 mg SC injection every 7 days
|
Dapagliflozin (DAPA)
n=23 Participants
DAPA-10 mg oral pill once daily in am for 24 weeks
Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am
|
EQW Plus DAPA
n=22 Participants
EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks
EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am
|
Dapagliflozin Plus Glucophage (MET ER)
n=26 Participants
Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks
Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose
|
Phentermine /Topiramate (PHEN/ TPM) ER
n=25 Participants
Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks
Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
29.6 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
29.2 years
STANDARD_DEVIATION 6.3 • n=7 Participants
|
31.4 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
29.6 years
STANDARD_DEVIATION 7.0 • n=4 Participants
|
29 years
STANDARD_DEVIATION 5.6 • n=21 Participants
|
29.9 years
STANDARD_DEVIATION 5.9 • n=8 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
119 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
34 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
85 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
22 participants
n=5 Participants
|
26 participants
n=4 Participants
|
25 participants
n=21 Participants
|
119 participants
n=8 Participants
|
|
Body Mass Index
|
38.6 kg/m^2
STANDARD_DEVIATION 5.1 • n=5 Participants
|
38 kg/m^2
STANDARD_DEVIATION 5.1 • n=7 Participants
|
39.9 kg/m^2
STANDARD_DEVIATION 4.2 • n=5 Participants
|
37.6 kg/m^2
STANDARD_DEVIATION 4.5 • n=4 Participants
|
38.4 kg/m^2
STANDARD_DEVIATION 4.4 • n=21 Participants
|
38.3 kg/m^2
STANDARD_DEVIATION 4.5 • n=8 Participants
|
PRIMARY outcome
Timeframe: 24 weeks of treatmentAn estimation of β-cell compensatory function, the insulin secretion-sensitivity index (IS-SI) will be derived by applying the concept of the oral disposition index to measurements obtained during the 2-h OGTT and calculated as the index of insulin secretion factored by insulin sensitivity (ΔINS/ΔPG 30 x Matsuda SIOGTT) from the OGTT. A higher score shows improved pancreatic insulin responsiveness relative to resistance.
Outcome measures
| Measure |
Exenatide Once Weekly (EQW )
n=20 Participants
EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks
Exenatide once weekly (EQW ): 2 mg SC injection every 7 days
|
Dapagliflozin (DAPA)
n=17 Participants
DAPA-10 mg oral pill once daily in am for 24 weeks
Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am
|
EQW Plus DAPA
n=20 Participants
EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks
EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am
|
Dapagliflozin Plus Glucophage (MET ER)
n=19 Participants
Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks
Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose
|
Phentermine /Topiramate (PHEN/ TPM) ER
n=16 Participants
Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks
Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am
|
|---|---|---|---|---|---|
|
Oral Disposition (Insulin Sensitivity-insulin Secretion) Index
|
471 index score
Standard Error 83
|
311 index score
Standard Error 90
|
503 index score
Standard Error 80
|
395 index score
Standard Error 85
|
545 index score
Standard Error 93
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentTreatment effect on body weight at 24 weeks of treatment
Outcome measures
| Measure |
Exenatide Once Weekly (EQW )
n=20 Participants
EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks
Exenatide once weekly (EQW ): 2 mg SC injection every 7 days
|
Dapagliflozin (DAPA)
n=17 Participants
DAPA-10 mg oral pill once daily in am for 24 weeks
Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am
|
EQW Plus DAPA
n=20 Participants
EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks
EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am
|
Dapagliflozin Plus Glucophage (MET ER)
n=19 Participants
Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks
Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose
|
Phentermine /Topiramate (PHEN/ TPM) ER
n=16 Participants
Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks
Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am
|
|---|---|---|---|---|---|
|
Absolute Body Weight
|
100.4 kilogram
Standard Error 3.7
|
102.6 kilogram
Standard Error 4
|
99 kilogram
Standard Error 3.7
|
101.2 kilogram
Standard Error 3.8
|
97 kilogram
Standard Error 4.1
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentTreatment efficacy in reducing body mass at 24 weeks of treatment
Outcome measures
| Measure |
Exenatide Once Weekly (EQW )
n=20 Participants
EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks
Exenatide once weekly (EQW ): 2 mg SC injection every 7 days
|
Dapagliflozin (DAPA)
n=17 Participants
DAPA-10 mg oral pill once daily in am for 24 weeks
Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am
|
EQW Plus DAPA
n=20 Participants
EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks
EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am
|
Dapagliflozin Plus Glucophage (MET ER)
n=19 Participants
Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks
Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose
|
Phentermine /Topiramate (PHEN/ TPM) ER
n=16 Participants
Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks
Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am
|
|---|---|---|---|---|---|
|
Body Mass Index (BMI)
|
37.3 kilogram/meter squared
Standard Error 1.1
|
37.4 kilogram/meter squared
Standard Error 1.2
|
36.7 kilogram/meter squared
Standard Error 1.1
|
37 kilogram/meter squared
Standard Error 1.2
|
35.3 kilogram/meter squared
Standard Error 1.3
|
SECONDARY outcome
Timeframe: Change from baseline (time 0) to study end (24 weeks)Treatment effect on change in percent body weight from baseline
Outcome measures
| Measure |
Exenatide Once Weekly (EQW )
n=20 Participants
EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks
Exenatide once weekly (EQW ): 2 mg SC injection every 7 days
|
Dapagliflozin (DAPA)
n=17 Participants
DAPA-10 mg oral pill once daily in am for 24 weeks
Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am
|
EQW Plus DAPA
n=20 Participants
EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks
EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am
|
Dapagliflozin Plus Glucophage (MET ER)
n=19 Participants
Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks
Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose
|
Phentermine /Topiramate (PHEN/ TPM) ER
n=16 Participants
Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks
Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am
|
|---|---|---|---|---|---|
|
Change in Percent Body Weight
|
3.8 percentage change in body weight
Standard Error 0.8
|
1.5 percentage change in body weight
Standard Error 1.4
|
6.9 percentage change in body weight
Standard Error 0.9
|
1.7 percentage change in body weight
Standard Error 1.0
|
8.1 percentage change in body weight
Standard Error 1.3
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentTreatment effect on loss of central adiposity after 24 weeks
Outcome measures
| Measure |
Exenatide Once Weekly (EQW )
n=20 Participants
EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks
Exenatide once weekly (EQW ): 2 mg SC injection every 7 days
|
Dapagliflozin (DAPA)
n=17 Participants
DAPA-10 mg oral pill once daily in am for 24 weeks
Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am
|
EQW Plus DAPA
n=20 Participants
EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks
EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am
|
Dapagliflozin Plus Glucophage (MET ER)
n=19 Participants
Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks
Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose
|
Phentermine /Topiramate (PHEN/ TPM) ER
n=16 Participants
Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks
Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am
|
|---|---|---|---|---|---|
|
Central Adiposity (Waist Circumference)
|
104 centimeters
Standard Error 3
|
101 centimeters
Standard Error 3.2
|
106 centimeters
Standard Error 3
|
101.3 centimeters
Standard Error 3
|
97 centimeters
Standard Error 3.4
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentTreatment impact on central adiposity after 24 weeks
Outcome measures
| Measure |
Exenatide Once Weekly (EQW )
n=20 Participants
EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks
Exenatide once weekly (EQW ): 2 mg SC injection every 7 days
|
Dapagliflozin (DAPA)
n=17 Participants
DAPA-10 mg oral pill once daily in am for 24 weeks
Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am
|
EQW Plus DAPA
n=20 Participants
EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks
EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am
|
Dapagliflozin Plus Glucophage (MET ER)
n=19 Participants
Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks
Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose
|
Phentermine /Topiramate (PHEN/ TPM) ER
n=16 Participants
Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks
Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am
|
|---|---|---|---|---|---|
|
Waist-to-Hip Ratio (WHR)
|
.83 ratio
Standard Error .016
|
.79 ratio
Standard Error .017
|
.86 ratio
Standard Error .016
|
.83 ratio
Standard Error .016
|
.81 ratio
Standard Error .018
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentTreatment impact on WHtR which is a measure of central adiposity
Outcome measures
| Measure |
Exenatide Once Weekly (EQW )
n=20 Participants
EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks
Exenatide once weekly (EQW ): 2 mg SC injection every 7 days
|
Dapagliflozin (DAPA)
n=17 Participants
DAPA-10 mg oral pill once daily in am for 24 weeks
Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am
|
EQW Plus DAPA
n=20 Participants
EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks
EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am
|
Dapagliflozin Plus Glucophage (MET ER)
n=19 Participants
Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks
Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose
|
Phentermine /Topiramate (PHEN/ TPM) ER
n=16 Participants
Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks
Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am
|
|---|---|---|---|---|---|
|
Waist-to-Height Ratio (WHtR)
|
.64 ratio
Standard Error .018
|
.61 ratio
Standard Error .02
|
.65 ratio
Standard Error .018
|
.61 ratio
Standard Error .019
|
.59 ratio
Standard Error .021
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentTreatment impact on total fat mass by DEXA
Outcome measures
| Measure |
Exenatide Once Weekly (EQW )
n=20 Participants
EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks
Exenatide once weekly (EQW ): 2 mg SC injection every 7 days
|
Dapagliflozin (DAPA)
n=17 Participants
DAPA-10 mg oral pill once daily in am for 24 weeks
Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am
|
EQW Plus DAPA
n=20 Participants
EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks
EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am
|
Dapagliflozin Plus Glucophage (MET ER)
n=19 Participants
Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks
Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose
|
Phentermine /Topiramate (PHEN/ TPM) ER
n=16 Participants
Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks
Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am
|
|---|---|---|---|---|---|
|
Total Fat Mass (kg) Evaluated by DEXA
|
47.6 kilogram
Standard Error 2.4
|
47.8 kilogram
Standard Error 2.6
|
45.9 kilogram
Standard Error 2.4
|
48 kilogram
Standard Error 2.5
|
44.5 kilogram
Standard Error 2.8
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentTreatment impact on percent total body fat by DEXA
Outcome measures
| Measure |
Exenatide Once Weekly (EQW )
n=20 Participants
EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks
Exenatide once weekly (EQW ): 2 mg SC injection every 7 days
|
Dapagliflozin (DAPA)
n=17 Participants
DAPA-10 mg oral pill once daily in am for 24 weeks
Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am
|
EQW Plus DAPA
n=20 Participants
EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks
EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am
|
Dapagliflozin Plus Glucophage (MET ER)
n=19 Participants
Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks
Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose
|
Phentermine /Topiramate (PHEN/ TPM) ER
n=16 Participants
Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks
Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am
|
|---|---|---|---|---|---|
|
Total Body Fat (%) by DEXA
|
46.1 percent fat mass
Standard Error 1.1
|
46.4 percent fat mass
Standard Error 1.2
|
45.8 percent fat mass
Standard Error 1.1
|
46.1 percent fat mass
Standard Error 1.1
|
45.2 percent fat mass
Standard Error 1.2
|
SECONDARY outcome
Timeframe: 24 weeks of treatmenttreatment impact on measure of central adiposity as determined by android/gynoid ratio
Outcome measures
| Measure |
Exenatide Once Weekly (EQW )
n=20 Participants
EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks
Exenatide once weekly (EQW ): 2 mg SC injection every 7 days
|
Dapagliflozin (DAPA)
n=17 Participants
DAPA-10 mg oral pill once daily in am for 24 weeks
Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am
|
EQW Plus DAPA
n=20 Participants
EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks
EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am
|
Dapagliflozin Plus Glucophage (MET ER)
n=19 Participants
Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks
Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose
|
Phentermine /Topiramate (PHEN/ TPM) ER
n=16 Participants
Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks
Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am
|
|---|---|---|---|---|---|
|
Android-Gynoid Ratio (AGR) as Determined by DEXA
|
1.07 ratio
Standard Error .024
|
1.02 ratio
Standard Error .03
|
1.04 ratio
Standard Error .02
|
1.04 ratio
Standard Error .03
|
1.03 ratio
Standard Error .03
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentTreatment impact on trunk/limb ratio (measure of central adiposity) by DEXA
Outcome measures
| Measure |
Exenatide Once Weekly (EQW )
n=20 Participants
EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks
Exenatide once weekly (EQW ): 2 mg SC injection every 7 days
|
Dapagliflozin (DAPA)
n=17 Participants
DAPA-10 mg oral pill once daily in am for 24 weeks
Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am
|
EQW Plus DAPA
n=20 Participants
EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks
EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am
|
Dapagliflozin Plus Glucophage (MET ER)
n=19 Participants
Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks
Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose
|
Phentermine /Topiramate (PHEN/ TPM) ER
n=16 Participants
Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks
Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am
|
|---|---|---|---|---|---|
|
Trunk/Leg Fat Ratio by DEXA
|
1.03 ratio
Standard Error .045
|
.95 ratio
Standard Error .048
|
.93 ratio
Standard Error .045
|
.98 ratio
Standard Error .047
|
.99 ratio
Standard Error .05
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentTreatment impact on fasting concentration of glucose in the blood
Outcome measures
| Measure |
Exenatide Once Weekly (EQW )
n=20 Participants
EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks
Exenatide once weekly (EQW ): 2 mg SC injection every 7 days
|
Dapagliflozin (DAPA)
n=17 Participants
DAPA-10 mg oral pill once daily in am for 24 weeks
Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am
|
EQW Plus DAPA
n=20 Participants
EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks
EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am
|
Dapagliflozin Plus Glucophage (MET ER)
n=19 Participants
Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks
Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose
|
Phentermine /Topiramate (PHEN/ TPM) ER
n=16 Participants
Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks
Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am
|
|---|---|---|---|---|---|
|
Fasting Blood Glucose
|
91 mg/dL
Standard Error 1.9
|
93 mg/dL
Standard Error 2.1
|
86.5 mg/dL
Standard Error 1.9
|
89 mg/dL
Standard Error 2.0
|
91.4 mg/dL
Standard Error 2.2
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentTreatment effect on MBG measured during the oral glucose tolerance test
Outcome measures
| Measure |
Exenatide Once Weekly (EQW )
n=20 Participants
EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks
Exenatide once weekly (EQW ): 2 mg SC injection every 7 days
|
Dapagliflozin (DAPA)
n=17 Participants
DAPA-10 mg oral pill once daily in am for 24 weeks
Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am
|
EQW Plus DAPA
n=20 Participants
EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks
EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am
|
Dapagliflozin Plus Glucophage (MET ER)
n=19 Participants
Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks
Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose
|
Phentermine /Topiramate (PHEN/ TPM) ER
n=16 Participants
Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks
Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am
|
|---|---|---|---|---|---|
|
OGTT Mean Blood Glucose (MBG)
|
118 mg/dL
Standard Error 4.8
|
126.4 mg/dL
Standard Error 5.2
|
112 mg/dL
Standard Error 4.8
|
119 mg/dL
Standard Error 4.9
|
113 mg/dL
Standard Error 5.4
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentTreatment effect on the ratio HOMA-IR which is insulin resistance measure derived from fasting blood glucose and insulin and is calculated by insulin (mU/ml)\*glucose (mmol/L)/22,5. The higher thenumber the more insulin resistant.
Outcome measures
| Measure |
Exenatide Once Weekly (EQW )
n=20 Participants
EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks
Exenatide once weekly (EQW ): 2 mg SC injection every 7 days
|
Dapagliflozin (DAPA)
n=17 Participants
DAPA-10 mg oral pill once daily in am for 24 weeks
Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am
|
EQW Plus DAPA
n=20 Participants
EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks
EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am
|
Dapagliflozin Plus Glucophage (MET ER)
n=19 Participants
Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks
Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose
|
Phentermine /Topiramate (PHEN/ TPM) ER
n=16 Participants
Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks
Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am
|
|---|---|---|---|---|---|
|
Fasting Insulin Sensitivity (HOMA-IR)
|
3.7 index score
Standard Error 0.55
|
3.6 index score
Standard Error 0.6
|
2.6 index score
Standard Error 0.55
|
3.3 index score
Standard Error 0.57
|
3.4 index score
Standard Error 0.62
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentThe SI IOGTT is a measure of peripheral insulin sensitivity derived from the values of Insulin (microunits per milliliter) and Glucose (milligrams per deciliter) obtained from the OGTT and the corresponding fasting values. SI (OGTT) = 10,000/ \[(G fasting x I fasting) x (G OGTTmean x I OGTTmean)\], where fasting glucose and insulin data are taken from time 0 of the OGTT and mean data represent the average glucose and insulin values obtained during the entire OGTT. The square root is used to correct for nonlinear distribution of insulin, and 10,000 is a scaling factor in the equation. The higher value, the more sensitive to insulin.
Outcome measures
| Measure |
Exenatide Once Weekly (EQW )
n=20 Participants
EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks
Exenatide once weekly (EQW ): 2 mg SC injection every 7 days
|
Dapagliflozin (DAPA)
n=17 Participants
DAPA-10 mg oral pill once daily in am for 24 weeks
Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am
|
EQW Plus DAPA
n=20 Participants
EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks
EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am
|
Dapagliflozin Plus Glucophage (MET ER)
n=19 Participants
Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks
Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose
|
Phentermine /Topiramate (PHEN/ TPM) ER
n=16 Participants
Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks
Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am
|
|---|---|---|---|---|---|
|
Matsuda Sensitivity Index Derived From the OGTT(SI OGTT)
|
3.1 index score
Standard Error 0.6
|
3.6 index score
Standard Error 0.7
|
3.9 index score
Standard Error 0.6
|
4.8 index score
Standard Error 0.6
|
4.7 index score
Standard Error 0.7
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentTreatment effect on insulin secretion from 0 to 30 minutes after glucose load corrected for by fasting insulin sensitivity. A higher score shows improved first phase insulin secretion in response to glucose
Outcome measures
| Measure |
Exenatide Once Weekly (EQW )
n=20 Participants
EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks
Exenatide once weekly (EQW ): 2 mg SC injection every 7 days
|
Dapagliflozin (DAPA)
n=17 Participants
DAPA-10 mg oral pill once daily in am for 24 weeks
Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am
|
EQW Plus DAPA
n=20 Participants
EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks
EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am
|
Dapagliflozin Plus Glucophage (MET ER)
n=19 Participants
Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks
Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose
|
Phentermine /Topiramate (PHEN/ TPM) ER
n=16 Participants
Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks
Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am
|
|---|---|---|---|---|---|
|
Corrected First Phase Insulin Secretion (IGI/HOMA-IR)
|
1.03 index score
Standard Error 0.2
|
0.6 index score
Standard Error 0.21
|
0.91 index score
Standard Error 0.2
|
0.7 index score
Standard Error 0.2
|
1.1 index score
Standard Error 0.22
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentTreatment effect on blood concentrations of total cholesterol
Outcome measures
| Measure |
Exenatide Once Weekly (EQW )
n=20 Participants
EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks
Exenatide once weekly (EQW ): 2 mg SC injection every 7 days
|
Dapagliflozin (DAPA)
n=17 Participants
DAPA-10 mg oral pill once daily in am for 24 weeks
Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am
|
EQW Plus DAPA
n=20 Participants
EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks
EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am
|
Dapagliflozin Plus Glucophage (MET ER)
n=19 Participants
Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks
Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose
|
Phentermine /Topiramate (PHEN/ TPM) ER
n=16 Participants
Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks
Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am
|
|---|---|---|---|---|---|
|
Total Cholesterol Levels
|
189 mg/dL
Standard Error 10
|
186 mg/dL
Standard Error 11
|
185 mg/dL
Standard Error 10
|
192 mg/dL
Standard Error 11
|
178 mg/dL
Standard Error 12
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentTreatment effect on blood concentrations of triglycerides
Outcome measures
| Measure |
Exenatide Once Weekly (EQW )
n=20 Participants
EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks
Exenatide once weekly (EQW ): 2 mg SC injection every 7 days
|
Dapagliflozin (DAPA)
n=17 Participants
DAPA-10 mg oral pill once daily in am for 24 weeks
Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am
|
EQW Plus DAPA
n=20 Participants
EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks
EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am
|
Dapagliflozin Plus Glucophage (MET ER)
n=19 Participants
Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks
Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose
|
Phentermine /Topiramate (PHEN/ TPM) ER
n=16 Participants
Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks
Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am
|
|---|---|---|---|---|---|
|
Triglyceride (TRG) Levels
|
130 mg/dL
Standard Error 12
|
132 mg/dL
Standard Error 13
|
112 mg/dL
Standard Error 12
|
105 mg/dL
Standard Error 12
|
110 mg/dL
Standard Error 13
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentTreatment effect on blood concentrations of total testosterone
Outcome measures
| Measure |
Exenatide Once Weekly (EQW )
n=20 Participants
EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks
Exenatide once weekly (EQW ): 2 mg SC injection every 7 days
|
Dapagliflozin (DAPA)
n=17 Participants
DAPA-10 mg oral pill once daily in am for 24 weeks
Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am
|
EQW Plus DAPA
n=20 Participants
EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks
EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am
|
Dapagliflozin Plus Glucophage (MET ER)
n=19 Participants
Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks
Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose
|
Phentermine /Topiramate (PHEN/ TPM) ER
n=16 Participants
Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks
Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am
|
|---|---|---|---|---|---|
|
Total Testosterone Concentrations
|
38.8 ng/dL
Standard Error 4
|
35 ng/dL
Standard Error 4.4
|
42.6 ng/dL
Standard Error 4
|
39.5 ng/dL
Standard Error 4.1
|
45.5 ng/dL
Standard Error 4.5
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentTreatment effect on blood concentrations of DHEA-S
Outcome measures
| Measure |
Exenatide Once Weekly (EQW )
n=20 Participants
EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks
Exenatide once weekly (EQW ): 2 mg SC injection every 7 days
|
Dapagliflozin (DAPA)
n=17 Participants
DAPA-10 mg oral pill once daily in am for 24 weeks
Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am
|
EQW Plus DAPA
n=20 Participants
EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks
EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am
|
Dapagliflozin Plus Glucophage (MET ER)
n=19 Participants
Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks
Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose
|
Phentermine /Topiramate (PHEN/ TPM) ER
n=16 Participants
Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks
Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am
|
|---|---|---|---|---|---|
|
Dehydroepiandrosterone Sulfate (DHEA-S) Levels
|
165 mcg/dL
Standard Error 22
|
187 mcg/dL
Standard Error 24
|
169 mcg/dL
Standard Error 22
|
189 mcg/dL
Standard Error 23
|
201 mcg/dL
Standard Error 24
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentTreatment effect on FAI calculated from total testosterone divided by sex hormone binding globulin (SHBG) levels. A higher score indicates a worse outcome.
Outcome measures
| Measure |
Exenatide Once Weekly (EQW )
n=20 Participants
EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks
Exenatide once weekly (EQW ): 2 mg SC injection every 7 days
|
Dapagliflozin (DAPA)
n=17 Participants
DAPA-10 mg oral pill once daily in am for 24 weeks
Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am
|
EQW Plus DAPA
n=20 Participants
EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks
EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am
|
Dapagliflozin Plus Glucophage (MET ER)
n=19 Participants
Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks
Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose
|
Phentermine /Topiramate (PHEN/ TPM) ER
n=16 Participants
Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks
Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am
|
|---|---|---|---|---|---|
|
Free Androgen Index (FAI)
|
5.3 index score
Standard Error 0.72
|
4.7 index score
Standard Error 0.8
|
5.2 index score
Standard Error 0.73
|
5.7 index score
Standard Error 0.74
|
5 index score
Standard Error 0.8
|
SECONDARY outcome
Timeframe: 24 weeks treatmentTreatment effect on SBP after 24 weeks of treatment
Outcome measures
| Measure |
Exenatide Once Weekly (EQW )
n=20 Participants
EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks
Exenatide once weekly (EQW ): 2 mg SC injection every 7 days
|
Dapagliflozin (DAPA)
n=17 Participants
DAPA-10 mg oral pill once daily in am for 24 weeks
Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am
|
EQW Plus DAPA
n=20 Participants
EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks
EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am
|
Dapagliflozin Plus Glucophage (MET ER)
n=19 Participants
Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks
Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose
|
Phentermine /Topiramate (PHEN/ TPM) ER
n=16 Participants
Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks
Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am
|
|---|---|---|---|---|---|
|
Systolic Blood Pressure (SBP)
|
123.6 mmHg
Standard Error 1.9
|
123 mmHg
Standard Error 2.0
|
122 mmHg
Standard Error 1.9
|
128 mmHg
Standard Error 1.8
|
124 mmHg
Standard Error 2.0
|
SECONDARY outcome
Timeframe: 24 weeks of treatmentTreatment effect on DBP after 24 weeks
Outcome measures
| Measure |
Exenatide Once Weekly (EQW )
n=20 Participants
EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks
Exenatide once weekly (EQW ): 2 mg SC injection every 7 days
|
Dapagliflozin (DAPA)
n=17 Participants
DAPA-10 mg oral pill once daily in am for 24 weeks
Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am
|
EQW Plus DAPA
n=20 Participants
EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks
EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am
|
Dapagliflozin Plus Glucophage (MET ER)
n=19 Participants
Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks
Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose
|
Phentermine /Topiramate (PHEN/ TPM) ER
n=16 Participants
Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks
Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am
|
|---|---|---|---|---|---|
|
Diastolic Blood Pressure (DBP)
|
81 mmHg
Standard Error 1.7
|
79.8 mmHg
Standard Error 1.9
|
76 mmHg
Standard Error 1.7
|
82 mmHg
Standard Error 1.8
|
83.6 mmHg
Standard Error 2.0
|
Adverse Events
Exenatide Once Weekly (EQW )
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Dapagliflozin (DAPA)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
EQW Plus DAPA
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Dapagliflozin Plus Glucophage (MET ER)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Phentermine /Topiramate (PHEN/ TPM) ER
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exenatide Once Weekly (EQW )
n=23 participants at risk
EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks
Exenatide once weekly (EQW ): 2 mg SC injection every 7 days
|
Dapagliflozin (DAPA)
n=23 participants at risk
DAPA-10 mg oral pill once daily in am for 24 weeks
Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am
|
EQW Plus DAPA
n=22 participants at risk
EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks
EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am
|
Dapagliflozin Plus Glucophage (MET ER)
n=26 participants at risk
Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks
Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose
|
Phentermine /Topiramate (PHEN/ TPM) ER
n=25 participants at risk
Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks
Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am
|
|---|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
8.7%
2/23 • 24 weeks
|
0.00%
0/23 • 24 weeks
|
0.00%
0/22 • 24 weeks
|
0.00%
0/26 • 24 weeks
|
8.0%
2/25 • 24 weeks
|
Other adverse events
| Measure |
Exenatide Once Weekly (EQW )
n=23 participants at risk
EQW- 2 mg subcutaneous (SC) injection once every seven days for 24 weeks
Exenatide once weekly (EQW ): 2 mg SC injection every 7 days
|
Dapagliflozin (DAPA)
n=23 participants at risk
DAPA-10 mg oral pill once daily in am for 24 weeks
Dapagliflozin (DAPA): One pill (10 mg) by mouth daily (QD) in am
|
EQW Plus DAPA
n=22 participants at risk
EQW- 2 mg SC injection once every seven days for 24 weeks DAPA-10 mg oral pill once daily in am daily for 24 weeks
EQW plus DAPA: 2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am
|
Dapagliflozin Plus Glucophage (MET ER)
n=26 participants at risk
Combination DAPA / MET ER-10 mg /2000 mg oral pill daily with food for 24 weeks
Dapagliflozin plus Glucophage (MET ER): DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose
|
Phentermine /Topiramate (PHEN/ TPM) ER
n=25 participants at risk
Combination Phentermine /Topiramate ER -7.5 mg/46mg pill once daily in am for 24 weeks
Phentermine /Topiramate (PHEN/ TPM) ER: PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am
|
|---|---|---|---|---|---|
|
Renal and urinary disorders
Yeast infection or urinary tract infection
|
0.00%
0/23 • 24 weeks
|
26.1%
6/23 • 24 weeks
|
31.8%
7/22 • 24 weeks
|
26.9%
7/26 • 24 weeks
|
0.00%
0/25 • 24 weeks
|
|
Gastrointestinal disorders
Nausea and upset stomach
|
21.7%
5/23 • 24 weeks
|
0.00%
0/23 • 24 weeks
|
0.00%
0/22 • 24 weeks
|
23.1%
6/26 • 24 weeks
|
12.0%
3/25 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
21.7%
5/23 • 24 weeks
|
0.00%
0/23 • 24 weeks
|
18.2%
4/22 • 24 weeks
|
0.00%
0/26 • 24 weeks
|
0.00%
0/25 • 24 weeks
|
|
Reproductive system and breast disorders
Vaginal irritation
|
0.00%
0/23 • 24 weeks
|
4.3%
1/23 • 24 weeks
|
4.5%
1/22 • 24 weeks
|
0.00%
0/26 • 24 weeks
|
0.00%
0/25 • 24 weeks
|
|
Cardiac disorders
Rapid heartbeat
|
0.00%
0/23 • 24 weeks
|
4.3%
1/23 • 24 weeks
|
0.00%
0/22 • 24 weeks
|
0.00%
0/26 • 24 weeks
|
4.0%
1/25 • 24 weeks
|
|
General disorders
Insomnia
|
0.00%
0/23 • 24 weeks
|
0.00%
0/23 • 24 weeks
|
0.00%
0/22 • 24 weeks
|
0.00%
0/26 • 24 weeks
|
12.0%
3/25 • 24 weeks
|
|
General disorders
Fatigue
|
0.00%
0/23 • 24 weeks
|
0.00%
0/23 • 24 weeks
|
0.00%
0/22 • 24 weeks
|
0.00%
0/26 • 24 weeks
|
8.0%
2/25 • 24 weeks
|
|
General disorders
Lightheaded
|
0.00%
0/23 • 24 weeks
|
4.3%
1/23 • 24 weeks
|
0.00%
0/22 • 24 weeks
|
0.00%
0/26 • 24 weeks
|
4.0%
1/25 • 24 weeks
|
|
General disorders
Headache
|
0.00%
0/23 • 24 weeks
|
0.00%
0/23 • 24 weeks
|
0.00%
0/22 • 24 weeks
|
0.00%
0/26 • 24 weeks
|
8.0%
2/25 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Stuffy Nose
|
0.00%
0/23 • 24 weeks
|
0.00%
0/23 • 24 weeks
|
0.00%
0/22 • 24 weeks
|
3.8%
1/26 • 24 weeks
|
0.00%
0/25 • 24 weeks
|
|
Reproductive system and breast disorders
Prolonged menstrual cycle
|
0.00%
0/23 • 24 weeks
|
4.3%
1/23 • 24 weeks
|
4.5%
1/22 • 24 weeks
|
0.00%
0/26 • 24 weeks
|
0.00%
0/25 • 24 weeks
|
|
Renal and urinary disorders
Kidney Stone
|
0.00%
0/23 • 24 weeks
|
0.00%
0/23 • 24 weeks
|
0.00%
0/22 • 24 weeks
|
0.00%
0/26 • 24 weeks
|
4.0%
1/25 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place