Trial Outcomes & Findings for A Study of LY2409021 on Blood Pressure and Pulse Rate in Participants With Type 2 Diabetes Mellitus (NCT NCT02091362)
NCT ID: NCT02091362
Last Updated: 2018-07-19
Results Overview
Systolic blood pressure obtained from Ambulatory Blood Pressure Monitoring (ABPM).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
270 participants
Primary outcome timeframe
Baseline, 6 Weeks
Results posted on
2018-07-19
Participant Flow
Participant milestones
| Measure |
LY2409021/Placebo
Period 1: Single daily dose of 20 milligrams (mg) LY2409021 administered orally for 6 weeks; Wash-out: 4 weeks; Period 2: Single daily dose of placebo administered orally for 6 weeks.
|
Placebo/LY2409021
Period 1: Single daily dose of placebo administered orally for 6 weeks; Wash-out: 4 weeks; Period 2: Single daily dose of 20 milligrams (mg) LY2409021 administered orally for 6 weeks.
|
|---|---|---|
|
Period 1
STARTED
|
133
|
137
|
|
Period 1
COMPLETED
|
128
|
133
|
|
Period 1
NOT COMPLETED
|
5
|
4
|
|
Wash-out
STARTED
|
128
|
133
|
|
Wash-out
COMPLETED
|
127
|
130
|
|
Wash-out
NOT COMPLETED
|
1
|
3
|
|
Period 2
STARTED
|
127
|
130
|
|
Period 2
COMPLETED
|
125
|
128
|
|
Period 2
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
LY2409021/Placebo
Period 1: Single daily dose of 20 milligrams (mg) LY2409021 administered orally for 6 weeks; Wash-out: 4 weeks; Period 2: Single daily dose of placebo administered orally for 6 weeks.
|
Placebo/LY2409021
Period 1: Single daily dose of placebo administered orally for 6 weeks; Wash-out: 4 weeks; Period 2: Single daily dose of 20 milligrams (mg) LY2409021 administered orally for 6 weeks.
|
|---|---|---|
|
Period 1
Protocol Violation
|
1
|
0
|
|
Period 1
Withdrawal by Subject
|
2
|
3
|
|
Period 1
Lost to Follow-up
|
0
|
1
|
|
Period 1
Adverse Event
|
2
|
0
|
|
Wash-out
Lost to Follow-up
|
1
|
1
|
|
Wash-out
Withdrawal by Subject
|
0
|
2
|
|
Period 2
Adverse Event
|
1
|
0
|
|
Period 2
Lost to Follow-up
|
0
|
1
|
|
Period 2
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
A Study of LY2409021 on Blood Pressure and Pulse Rate in Participants With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
LY2409021 20 mg
n=133 Participants
Period 1: Single daily dose of 20 mg LY2409021 administered orally for 6 Weeks; Wash-out: 4 weeks; Period 2: Single daily dose of placebo administered orally for 6 weeks.
|
Placebo
n=137 Participants
Period 1: Single daily dose of placebo administered orally for 6 weeks; Wash-out: 4 weeks; Period 2: Single daily dose of 20 mg Ly2409021 administered orally for 6 weeks.
|
Total
n=270 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
57.2 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
57.7 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
63 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
92 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
72 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Diagnosis of Hypertension
Yes
|
89 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Diagnosis of Hypertension
No
|
44 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Hemoglobin A1c (HBA1c)
≥ 7.5 %
|
49 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Hemoglobin A1c (HBA1c)
< 7.5%
|
84 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 WeeksPopulation: Modified intent-to-treat (mITT) population consisting of all randomized subjects who received at least one dose of study drug.
Systolic blood pressure obtained from Ambulatory Blood Pressure Monitoring (ABPM).
Outcome measures
| Measure |
LY2409021 20 mg
n=241 Participants
Single daily dose of 20 milligrams (mg) LY2409021 administered orally in 1 of 2 treatment periods
|
Placebo
n=239 Participants
Single daily dose of placebo matching LY2409021 administered orally in 1 of 2 treatment periods
|
|---|---|---|
|
Change From Baseline to 6 Weeks in Mean 24-Hour Systolic Blood Pressure
|
2.79 mmHg
Interval 1.62 to 3.95
|
0.53 mmHg
Interval -0.7 to 1.76
|
SECONDARY outcome
Timeframe: Baseline, 6 WeeksPopulation: Modified intent-to-treat (mITT) population consisting of all randomized subjects who received at least one dose of study drug.
Diastolic blood pressure obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate.
Outcome measures
| Measure |
LY2409021 20 mg
n=241 Participants
Single daily dose of 20 milligrams (mg) LY2409021 administered orally in 1 of 2 treatment periods
|
Placebo
n=239 Participants
Single daily dose of placebo matching LY2409021 administered orally in 1 of 2 treatment periods
|
|---|---|---|
|
Change From Baseline to 6 Weeks in Mean 24-Hour Diastolic Blood Pressure
|
1.37 mmHg
Interval 0.61 to 2.14
|
0.00 mmHg
Interval -0.76 to 0.77
|
SECONDARY outcome
Timeframe: Baseline, 6 WeeksPopulation: Modified intent-to-treat (mITT) population consisting of all randomized subjects who received at least one dose of study drug.
Pulse rate obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate.
Outcome measures
| Measure |
LY2409021 20 mg
n=241 Participants
Single daily dose of 20 milligrams (mg) LY2409021 administered orally in 1 of 2 treatment periods
|
Placebo
n=239 Participants
Single daily dose of placebo matching LY2409021 administered orally in 1 of 2 treatment periods
|
|---|---|---|
|
Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Peripheral Pulse Rate
24 Hour Pulse Rate
|
0.46 beats/minute
Interval -0.46 to 1.37
|
0.43 beats/minute
Interval -0.53 to 1.4
|
|
Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Peripheral Pulse Rate
Mean Daytime Pulse Rate
|
0.74 beats/minute
Interval -0.26 to 1.75
|
0.56 beats/minute
Interval -0.48 to 1.61
|
|
Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Peripheral Pulse Rate
Mean Nighttime Pulse Rate
|
-0.39 beats/minute
Interval -1.35 to 0.57
|
-0.04 beats/minute
Interval -1.03 to 0.96
|
SECONDARY outcome
Timeframe: Baseline, 6 WeeksPopulation: Modified intent-to-treat (mITT) population consisting of all randomized subjects who received at least one dose of study drug.
Pulse Pressures obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate.
Outcome measures
| Measure |
LY2409021 20 mg
n=241 Participants
Single daily dose of 20 milligrams (mg) LY2409021 administered orally in 1 of 2 treatment periods
|
Placebo
n=239 Participants
Single daily dose of placebo matching LY2409021 administered orally in 1 of 2 treatment periods
|
|---|---|---|
|
Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Pulse Pressures
Daytime Pulse Pressure
|
1.49 mmHg
Interval 0.68 to 2.29
|
0.54 mmHg
Interval -0.29 to 1.38
|
|
Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Pulse Pressures
Nighttime Pulse Pressure
|
1.51 mmHg
Interval 0.69 to 2.32
|
0.80 mmHg
Interval 0.0 to 1.6
|
|
Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Pulse Pressures
24-Hour Pulse Pressure
|
1.51 mmHg
Interval 0.76 to 2.25
|
0.62 mmHg
Interval -0.13 to 1.38
|
SECONDARY outcome
Timeframe: Baseline, 6 WeeksPopulation: Modified intent-to-treat (mITT) population consisting of all randomized subjects who received at least one dose of study drug.
Mean Arterial Pressures obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate.
Outcome measures
| Measure |
LY2409021 20 mg
n=241 Participants
Single daily dose of 20 milligrams (mg) LY2409021 administered orally in 1 of 2 treatment periods
|
Placebo
n=239 Participants
Single daily dose of placebo matching LY2409021 administered orally in 1 of 2 treatment periods
|
|---|---|---|
|
Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Mean Arterial Pressures (MAP)
Daytime MAP
|
2.04 mmHg
Interval 1.14 to 2.94
|
0.08 mmHg
Interval -0.86 to 1.03
|
|
Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Mean Arterial Pressures (MAP)
24 Hour MAP
|
1.83 mmHg
Interval 0.99 to 2.68
|
0.17 mmHg
Interval -0.71 to 1.04
|
|
Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Mean Arterial Pressures (MAP)
Nighttime MAP
|
1.31 mmHg
Interval 0.33 to 2.29
|
0.33 mmHg
Interval -0.68 to 1.33
|
SECONDARY outcome
Timeframe: Baseline, 6 WeeksPopulation: Modified intent-to-treat (mITT) population consisting of all randomized subjects who received at least one dose of study drug.
LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate.
Outcome measures
| Measure |
LY2409021 20 mg
n=241 Participants
Single daily dose of 20 milligrams (mg) LY2409021 administered orally in 1 of 2 treatment periods
|
Placebo
n=239 Participants
Single daily dose of placebo matching LY2409021 administered orally in 1 of 2 treatment periods
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c)
|
-0.65 percentage of HbA1c
Interval -0.72 to -0.58
|
-0.16 percentage of HbA1c
Interval -0.23 to -0.08
|
SECONDARY outcome
Timeframe: Days 7, 21, 42, 70, 77, 91, 112, 140; 15 minute Predose and Days 7 and 77: 1 hour Postdose.Population: Modified intent-to-treat (mITT) population consisting of all randomized subjects who received at least one dose of study drug.
Population pharmacokinetic parameter apparent clearance (CL/F) is the apparent volume of the body fluid cleared of the drug per unit of time and was estimated by modeling of LY2409021 plasma concentration data from all LY2409021 groups.
Outcome measures
| Measure |
LY2409021 20 mg
n=249 Participants
Single daily dose of 20 milligrams (mg) LY2409021 administered orally in 1 of 2 treatment periods
|
Placebo
Single daily dose of placebo matching LY2409021 administered orally in 1 of 2 treatment periods
|
|---|---|---|
|
Population Pharmacokinetics: Apparent Clearance of LY2409021
|
0.406 Liter per hour (L/hr)
Geometric Coefficient of Variation 30.7
|
—
|
SECONDARY outcome
Timeframe: Days 7, 21, 42, 70, 77, 91, 112, 140; Predose and Days 7 and 77: 1 hour Postdose.Population: All randomized participants who received at least 1 one dose of study drug and had at least one measureable drug concentration.
Population pharmacokinetic parameter, apparent volume of distribution (V/F) is a theoretical volume that a drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma. Apparent volume of distribution (V/F) was estimated by modeling of LY2409021 plasma concentration data from all LY2409021 groups.
Outcome measures
| Measure |
LY2409021 20 mg
n=249 Participants
Single daily dose of 20 milligrams (mg) LY2409021 administered orally in 1 of 2 treatment periods
|
Placebo
Single daily dose of placebo matching LY2409021 administered orally in 1 of 2 treatment periods
|
|---|---|---|
|
Population Pharmacokinetics: Apparent Volume of Distribution of LY2409021
|
36.7 Liters
Geometric Coefficient of Variation 23.2
|
—
|
Adverse Events
LY2409021 20 mg
Serious events: 4 serious events
Other events: 49 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 32 other events
Deaths: 0 deaths
Wash-out
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Follow-up
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LY2409021 20 mg
n=258 participants at risk
AEs (Adverse Event) from Period 1 and 2 combined from LY2409021 20 mg administration
|
Placebo
n=256 participants at risk
AEs from Period 1 and 2 combined from placebo administration.
|
Wash-out
n=249 participants at risk
All AEs included during wash-out period.
|
Follow-up
n=253 participants at risk
All AEs from follow-up period.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/258
|
0.00%
0/256
|
0.00%
0/249
|
0.40%
1/253 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/258
|
0.39%
1/256 • Number of events 1
|
0.00%
0/249
|
0.00%
0/253
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/258
|
0.00%
0/256
|
0.00%
0/249
|
0.40%
1/253 • Number of events 1
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/258
|
0.39%
1/256 • Number of events 1
|
0.00%
0/249
|
0.40%
1/253 • Number of events 1
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/258
|
0.39%
1/256 • Number of events 1
|
0.00%
0/249
|
0.40%
1/253 • Number of events 1
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/258
|
0.39%
1/256 • Number of events 1
|
0.00%
0/249
|
0.00%
0/253
|
|
Investigations
Liver function test abnormal
|
0.39%
1/258 • Number of events 1
|
0.00%
0/256
|
0.00%
0/249
|
0.40%
1/253 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/258
|
0.00%
0/256
|
0.40%
1/249 • Number of events 1
|
0.00%
0/253
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.39%
1/258 • Number of events 1
|
0.00%
0/256
|
0.00%
0/249
|
0.40%
1/253 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/258
|
0.00%
0/256
|
0.40%
1/249 • Number of events 1
|
0.00%
0/253
|
|
Nervous system disorders
Cerebrovascular accident
|
0.39%
1/258 • Number of events 1
|
0.00%
0/256
|
0.00%
0/249
|
0.00%
0/253
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.39%
1/258 • Number of events 1
|
0.00%
0/256
|
0.00%
0/249
|
0.00%
0/253
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/258
|
0.00%
0/256
|
0.40%
1/249 • Number of events 1
|
0.00%
0/253
|
|
Vascular disorders
Hypertension
|
0.39%
1/258 • Number of events 1
|
0.00%
0/256
|
0.00%
0/249
|
0.00%
0/253
|
Other adverse events
| Measure |
LY2409021 20 mg
n=258 participants at risk
AEs (Adverse Event) from Period 1 and 2 combined from LY2409021 20 mg administration
|
Placebo
n=256 participants at risk
AEs from Period 1 and 2 combined from placebo administration.
|
Wash-out
n=249 participants at risk
All AEs included during wash-out period.
|
Follow-up
n=253 participants at risk
All AEs from follow-up period.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.2%
3/258 • Number of events 4
|
0.00%
0/256
|
0.00%
0/249
|
0.00%
0/253
|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
6/258 • Number of events 6
|
1.2%
3/256 • Number of events 3
|
1.2%
3/249 • Number of events 3
|
0.00%
0/253
|
|
Gastrointestinal disorders
Dyspepsia
|
1.2%
3/258 • Number of events 3
|
0.00%
0/256
|
0.00%
0/249
|
0.40%
1/253 • Number of events 1
|
|
General disorders
Fatigue
|
0.78%
2/258 • Number of events 2
|
1.6%
4/256 • Number of events 4
|
0.80%
2/249 • Number of events 2
|
0.79%
2/253 • Number of events 2
|
|
Infections and infestations
Influenza
|
1.6%
4/258 • Number of events 4
|
0.39%
1/256 • Number of events 1
|
0.00%
0/249
|
0.79%
2/253 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
0.78%
2/258 • Number of events 2
|
1.2%
3/256 • Number of events 3
|
1.2%
3/249 • Number of events 3
|
1.2%
3/253 • Number of events 3
|
|
Investigations
Alanine aminotransferase increased
|
4.7%
12/258 • Number of events 12
|
0.39%
1/256 • Number of events 1
|
1.6%
4/249 • Number of events 4
|
2.8%
7/253 • Number of events 7
|
|
Investigations
Aspartate aminotransferase increased
|
2.3%
6/258 • Number of events 6
|
0.78%
2/256 • Number of events 2
|
0.80%
2/249 • Number of events 2
|
1.2%
3/253 • Number of events 3
|
|
Investigations
Blood pressure diastolic increased
|
1.2%
3/258 • Number of events 3
|
1.2%
3/256 • Number of events 3
|
0.80%
2/249 • Number of events 2
|
0.79%
2/253 • Number of events 2
|
|
Investigations
Heart rate decreased
|
1.2%
3/258 • Number of events 4
|
0.78%
2/256 • Number of events 3
|
0.00%
0/249
|
0.00%
0/253
|
|
Investigations
Heart rate increased
|
1.6%
4/258 • Number of events 6
|
1.2%
3/256 • Number of events 3
|
0.40%
1/249 • Number of events 1
|
0.40%
1/253 • Number of events 1
|
|
Investigations
Hepatic enzyme increased
|
1.2%
3/258 • Number of events 3
|
0.39%
1/256 • Number of events 1
|
0.80%
2/249 • Number of events 2
|
0.40%
1/253 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.2%
3/258 • Number of events 3
|
0.39%
1/256 • Number of events 1
|
0.80%
2/249 • Number of events 2
|
0.00%
0/253
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.3%
6/258 • Number of events 6
|
1.2%
3/256 • Number of events 3
|
1.2%
3/249 • Number of events 5
|
1.2%
3/253 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
1.2%
3/258 • Number of events 4
|
0.39%
1/256 • Number of events 1
|
0.40%
1/249 • Number of events 1
|
0.40%
1/253 • Number of events 1
|
|
Nervous system disorders
Headache
|
1.6%
4/258 • Number of events 5
|
1.6%
4/256 • Number of events 4
|
0.80%
2/249 • Number of events 3
|
1.2%
3/253 • Number of events 5
|
|
Vascular disorders
Hypertension
|
0.78%
2/258 • Number of events 2
|
1.2%
3/256 • Number of events 3
|
0.80%
2/249 • Number of events 2
|
2.0%
5/253 • Number of events 5
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60