Trial Outcomes & Findings for Safety and Efficacy of Oral GKT137831 in Patient With Type 2 Diabetes and Albuminuria (NCT NCT02010242)
NCT ID: NCT02010242
Last Updated: 2025-02-28
Results Overview
UACR from baseline to Visits 9, 10, and 11 (i.e. weeks 8, 10 and 12 of the treatment period, respectively). Baseline for UACR is defined as the geometric mean of the geometric means of the UACR values measured on Day-14 (visit 4) and Day 1 (visit 5). End of treatment is defined as the geometric mean of the geometric means of the UACR values measured at week 8 (visit 9), week 10 (visit 10) and week 12 (visit 11).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
136 participants
Primary outcome timeframe
Visit 4 (week -2) to visit 11 (week 12)
Results posted on
2025-02-28
Participant Flow
Participant milestones
| Measure |
GKT137831
GKT137831 100 mg capsules twice a day
GKT137831: 1 capsule of 100 mg twice a day for the first 6 weeks of treatment, and 2 capsules of 100 mg twice a day for next 6 weeks of treatment
|
Placebo
Placebo capsule twice a day
Placebo: 1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
68
|
|
Overall Study
COMPLETED
|
64
|
61
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Oral GKT137831 in Patient With Type 2 Diabetes and Albuminuria
Baseline characteristics by cohort
| Measure |
GKT137831
n=68 Participants
GKT137831 100 mg capsules twice a day
GKT137831: 1 capsule of 100 mg twice a day for the first 6 weeks of treatment, and 2 capsules of 100 mg twice a day for next 6 weeks of treatment
|
Placebo
n=68 Participants
Placebo capsule twice a day
Placebo: 1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment.
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
30 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Age, Continuous
|
62.1 Years
STANDARD_DEVIATION 8.64 • n=5 Participants
|
62.2 Years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
62.1 Years
STANDARD_DEVIATION 9.24 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
12 participants
n=5 Participants
|
9 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
30 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
13 participants
n=5 Participants
|
8 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
5 participants
n=5 Participants
|
8 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
5 participants
n=5 Participants
|
11 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
7 participants
n=5 Participants
|
2 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 4 (week -2) to visit 11 (week 12)Population: Number of subjects analyzed in the Intent to Treat population who have evaluable results
UACR from baseline to Visits 9, 10, and 11 (i.e. weeks 8, 10 and 12 of the treatment period, respectively). Baseline for UACR is defined as the geometric mean of the geometric means of the UACR values measured on Day-14 (visit 4) and Day 1 (visit 5). End of treatment is defined as the geometric mean of the geometric means of the UACR values measured at week 8 (visit 9), week 10 (visit 10) and week 12 (visit 11).
Outcome measures
| Measure |
GKT137831
n=62 Participants
GKT137831 100 mg capsules twice a day
GKT137831: 1 capsule of 100 mg twice a day for the first 6 weeks of treatment, and 2 capsules of 100 mg twice a day for next 6 weeks of treatment
|
Placebo
n=59 Participants
Placebo capsule twice a day
Placebo: 1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment.
|
|---|---|---|
|
Albuminuria Absolute Value and Ratio to Baseline by Study Visit and Treatment Group
Baseline Geom. Mean
|
705.72 mg/g
Interval 637.07 to 774.36
|
696.30 mg/g
Interval 611.98 to 780.61
|
|
Albuminuria Absolute Value and Ratio to Baseline by Study Visit and Treatment Group
Adjusted End of treatment Geom. Mean
|
758.22 mg/g
Interval 695.61 to 826.46
|
705.29 mg/g
Interval 646.19 to 769.8
|
SECONDARY outcome
Timeframe: Visits 5 (week 0), 8 (week 6), and 11 (week 12)Population: Number of subjects analyzed in the Intent to treat population who have evaluable results
Change in homeostasis model assessment-estimated β cell function (HOMA-B) and homeostasis model assessment-estimated insulin resistance (HOMA-IR) from baseline. HOMA-IR = fasting insulin (μIU/mL) x fasting glucose (mM/L)/22.5. A higher HOMA-IR value indicates greater insulin resistance. HOMA-B = 20 x fasting insulin (μIU/mL)/(fasting glucose \[mmol/mL\] - 3.5). Generally, a higher HOMA-B value indicates better beta-cell function, meaning the pancreas is producing insulin effectively.
Outcome measures
| Measure |
GKT137831
n=10 Participants
GKT137831 100 mg capsules twice a day
GKT137831: 1 capsule of 100 mg twice a day for the first 6 weeks of treatment, and 2 capsules of 100 mg twice a day for next 6 weeks of treatment
|
Placebo
n=10 Participants
Placebo capsule twice a day
Placebo: 1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment.
|
|---|---|---|
|
Glucose Metabolism by Homeostatic Model Assessment (HOMA)
HOMA-IR Week 6 change from baseline
|
0.916 score on a scale
Standard Deviation 2.84
|
2.013 score on a scale
Standard Deviation 1.943
|
|
Glucose Metabolism by Homeostatic Model Assessment (HOMA)
HOMA-IR Week 12 change from baseline
|
0.344 score on a scale
Standard Deviation 2.32
|
-1.833 score on a scale
Standard Deviation 3.95
|
|
Glucose Metabolism by Homeostatic Model Assessment (HOMA)
HOMA-B Week 6 change from baseline
|
12.94 score on a scale
Standard Deviation 24.06
|
50.10 score on a scale
Standard Deviation 75.81
|
|
Glucose Metabolism by Homeostatic Model Assessment (HOMA)
HOMA-B Week 12 change from baseline
|
-12.41 score on a scale
Standard Deviation 38.72
|
47.63 score on a scale
Standard Deviation 120.18
|
SECONDARY outcome
Timeframe: Visit 5 (week 0), 8 (week 6) and 11 (week 12)Population: Number of subjects in the Intend to Treat Population who have evaluable results
Change in HbA1c from Baseline
Outcome measures
| Measure |
GKT137831
n=68 Participants
GKT137831 100 mg capsules twice a day
GKT137831: 1 capsule of 100 mg twice a day for the first 6 weeks of treatment, and 2 capsules of 100 mg twice a day for next 6 weeks of treatment
|
Placebo
n=68 Participants
Placebo capsule twice a day
Placebo: 1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment.
|
|---|---|---|
|
Glucose Metabolism HbA1c
Week 6 change from baseline
|
0.02 percentage of glycated haemoglobin
Standard Deviation 0.538
|
-0.03 percentage of glycated haemoglobin
Standard Deviation 0.618
|
|
Glucose Metabolism HbA1c
Week 12 change from baseline
|
0.12 percentage of glycated haemoglobin
Standard Deviation 0.659
|
0.03 percentage of glycated haemoglobin
Standard Deviation 0.722
|
SECONDARY outcome
Timeframe: Visits 5 (week 0) and 11 (week 12)Population: Number of subjects analyzed in the intent to treat population who have evaluable results
Change in 24 hours Albumin excretion from baseline
Outcome measures
| Measure |
GKT137831
n=67 Participants
GKT137831 100 mg capsules twice a day
GKT137831: 1 capsule of 100 mg twice a day for the first 6 weeks of treatment, and 2 capsules of 100 mg twice a day for next 6 weeks of treatment
|
Placebo
n=68 Participants
Placebo capsule twice a day
Placebo: 1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment.
|
|---|---|---|
|
24 Hours Albumin Excretion
|
389.82 mg/24hrs
Standard Deviation 1540.30
|
-56.15 mg/24hrs
Standard Deviation 1569.23
|
SECONDARY outcome
Timeframe: Visits 5 (week 0) and 11 (week 12)Population: Number of subjects analyzed in the intent to treat population who have evaluable results
Change in 24 hours Urine UACR from baseline
Outcome measures
| Measure |
GKT137831
n=67 Participants
GKT137831 100 mg capsules twice a day
GKT137831: 1 capsule of 100 mg twice a day for the first 6 weeks of treatment, and 2 capsules of 100 mg twice a day for next 6 weeks of treatment
|
Placebo
n=68 Participants
Placebo capsule twice a day
Placebo: 1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment.
|
|---|---|---|
|
24 Hours Urine UACR
|
220.15 mg/g
Standard Deviation 592.995
|
169.98 mg/g
Standard Deviation 706.38
|
SECONDARY outcome
Timeframe: Visits 5 (week 0), 6 (week 2), 7 (week 4), 8 (week 6), 9 (week 8), 10 (week 10), 11 (week 12), follow up (week 16)Population: Number of subjects analyzed in the intent to treat Population who have evaluable results
Change in eGFR from baseline by study visit
Outcome measures
| Measure |
GKT137831
n=68 Participants
GKT137831 100 mg capsules twice a day
GKT137831: 1 capsule of 100 mg twice a day for the first 6 weeks of treatment, and 2 capsules of 100 mg twice a day for next 6 weeks of treatment
|
Placebo
n=68 Participants
Placebo capsule twice a day
Placebo: 1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment.
|
|---|---|---|
|
eGFR Change by Study Visit
Change in week 2 (Visit 6) eGFR from baseline
|
-0.5 mL/min/1.73m^2
Standard Deviation 6.07
|
-0.4 mL/min/1.73m^2
Standard Deviation 7.27
|
|
eGFR Change by Study Visit
Change in week 4 (Visit 7) eGFR from baseline
|
-0.6 mL/min/1.73m^2
Standard Deviation 8.25
|
-1.5 mL/min/1.73m^2
Standard Deviation 6.55
|
|
eGFR Change by Study Visit
Change in week 6 (Visit 8) eGFR from baseline
|
-0.1 mL/min/1.73m^2
Standard Deviation 8.13
|
-0.3 mL/min/1.73m^2
Standard Deviation 6.80
|
|
eGFR Change by Study Visit
Change in week 8 (Visit 9) eGFR from baseline
|
-1.1 mL/min/1.73m^2
Standard Deviation 8.7
|
-1.7 mL/min/1.73m^2
Standard Deviation 7.31
|
|
eGFR Change by Study Visit
Change in week 10 (Visit 10) eGFR from baseline
|
-0.7 mL/min/1.73m^2
Standard Deviation 8.21
|
-1.9 mL/min/1.73m^2
Standard Deviation 7.89
|
|
eGFR Change by Study Visit
Change in week 12 (Visit 11) eGFR from baseline
|
-1.5 mL/min/1.73m^2
Standard Deviation 8.28
|
-1.2 mL/min/1.73m^2
Standard Deviation 8.08
|
|
eGFR Change by Study Visit
Change in week 16 (Follow up) eGFR from baseline
|
-1.3 mL/min/1.73m^2
Standard Deviation 8.21
|
-1.9 mL/min/1.73m^2
Standard Deviation 10.45
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visits 5 (week 0), and 11 (week 12)Population: Number of subjects analyzed in the Intent to Treat population who have evaluable results
Changes at week 12 in IEFF questionnaire assessing erectile dysfunction in patients presenting with these diabetic complications at baseline (Baseline \<=25 in the erectile function domain)- Score from 1 to 30. Score 1 to 10: severe erectile dysfunction, Score 11-16: moderate erectile dysfunction, Score 17-25: light erectile dysfunction, Score 26-30: normal erectile function
Outcome measures
| Measure |
GKT137831
n=46 Participants
GKT137831 100 mg capsules twice a day
GKT137831: 1 capsule of 100 mg twice a day for the first 6 weeks of treatment, and 2 capsules of 100 mg twice a day for next 6 weeks of treatment
|
Placebo
n=45 Participants
Placebo capsule twice a day
Placebo: 1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment.
|
|---|---|---|
|
Erectile Dysfunction
|
0.8 score on a scale
Standard Deviation 5.86
|
-0.5 score on a scale
Standard Deviation 5.06
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visits 5 (week 0), and 11 (week 12)Population: Number of subjects analyzed in the Intent to treat population who have evaluable results
Changes in Visual Analog Scale (VAS) assessing neuropathic leg pain in patients presenting with these diabetic complications at baseline (subjects with a baseline VAS\>=20mm are included). A 100mm VAS scale was used with a range from 0-100mm where a higher score means worse pain. The presence of neuropathic pain is defined a VAS score of at least 20 mm.
Outcome measures
| Measure |
GKT137831
n=31 Participants
GKT137831 100 mg capsules twice a day
GKT137831: 1 capsule of 100 mg twice a day for the first 6 weeks of treatment, and 2 capsules of 100 mg twice a day for next 6 weeks of treatment
|
Placebo
n=31 Participants
Placebo capsule twice a day
Placebo: 1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment.
|
|---|---|---|
|
Neuropathic Pain
|
-15.3 score on a scale
Standard Deviation 21.79
|
-10.5 score on a scale
Standard Deviation 22.18
|
Adverse Events
GKT137831
Serious events: 3 serious events
Other events: 33 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GKT137831
n=68 participants at risk
GKT137831 100 mg capsules twice a day
GKT137831: 1 capsule of 100 mg twice a day for the first 6 weeks of treatment, and 2 capsules of 100 mg twice a day for next 6 weeks of treatment
|
Placebo
n=68 participants at risk
Placebo capsule twice a day
Placebo: 1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/68 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
1.5%
1/68 • Number of events 1 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/68 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
1.5%
1/68 • Number of events 1 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
General disorders
Non-cardiac chest pain
|
1.5%
1/68 • Number of events 1 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
1.5%
1/68 • Number of events 1 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
Infections and infestations
Lobular Pneumonia
|
0.00%
0/68 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
1.5%
1/68 • Number of events 1 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
Infections and infestations
Pneumonia
|
1.5%
1/68 • Number of events 1 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
0.00%
0/68 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
Infections and infestations
Urinary Tract infection
|
0.00%
0/68 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
1.5%
1/68 • Number of events 1 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.5%
1/68 • Number of events 1 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
0.00%
0/68 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Cell Lung Cancer
|
0.00%
0/68 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
1.5%
1/68 • Number of events 1 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
Nervous system disorders
Hypoglycemic encephalopathy
|
0.00%
0/68 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
1.5%
1/68 • Number of events 1 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
Other adverse events
| Measure |
GKT137831
n=68 participants at risk
GKT137831 100 mg capsules twice a day
GKT137831: 1 capsule of 100 mg twice a day for the first 6 weeks of treatment, and 2 capsules of 100 mg twice a day for next 6 weeks of treatment
|
Placebo
n=68 participants at risk
Placebo capsule twice a day
Placebo: 1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment.
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
2.9%
2/68 • Number of events 2 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
2.9%
2/68 • Number of events 2 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
Infections and infestations
Nasopharyngitis
|
2.9%
2/68 • Number of events 2 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
2.9%
2/68 • Number of events 2 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/68 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
2.9%
2/68 • Number of events 2 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
4/68 • Number of events 4 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
2.9%
2/68 • Number of events 2 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
Infections and infestations
Urinary Tract infection
|
2.9%
2/68 • Number of events 2 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
2.9%
2/68 • Number of events 2 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
Gastrointestinal disorders
Constipation
|
2.9%
2/68 • Number of events 2 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
0.00%
0/68 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
Gastrointestinal disorders
Diarrhea
|
4.4%
3/68 • Number of events 3 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
5.9%
4/68 • Number of events 5 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/68 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
2.9%
2/68 • Number of events 2 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
Musculoskeletal and connective tissue disorders
Anthralgia
|
0.00%
0/68 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
2.9%
2/68 • Number of events 2 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
1/68 • Number of events 1 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
4.4%
3/68 • Number of events 4 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.9%
2/68 • Number of events 2 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
0.00%
0/68 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/68 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
4.4%
3/68 • Number of events 3 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
General disorders
Fatigue
|
0.00%
0/68 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
2.9%
2/68 • Number of events 2 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
General disorders
Non-cardiac chest pain
|
1.5%
1/68 • Number of events 1 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
4.4%
3/68 • Number of events 3 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
General disorders
Edema peripheral
|
2.9%
2/68 • Number of events 2 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
8.8%
6/68 • Number of events 6 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
Nervous system disorders
Dizziness
|
1.5%
1/68 • Number of events 1 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
4.4%
3/68 • Number of events 3 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
Nervous system disorders
Headache
|
2.9%
2/68 • Number of events 2 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
2.9%
2/68 • Number of events 2 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
Injury, poisoning and procedural complications
Limb Injury
|
2.9%
2/68 • Number of events 2 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
1.5%
1/68 • Number of events 1 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.5%
1/68 • Number of events 1 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
4.4%
3/68 • Number of events 4 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.9%
2/68 • Number of events 2 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
0.00%
0/68 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
Investigations
Blood Thyroid Stimulating Hormone increased
|
1.5%
1/68 • Number of events 1 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
2.9%
2/68 • Number of events 2 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
2.9%
2/68 • Number of events 2 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
0.00%
0/68 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic disorders
|
2.9%
2/68 • Number of events 2 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
4.4%
3/68 • Number of events 5 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
Vascular disorders
Hypertension
|
0.00%
0/68 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
2.9%
2/68 • Number of events 3 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
Cardiac disorders
Cardiac disorders
|
1.5%
1/68 • Number of events 1 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
5.9%
4/68 • Number of events 4 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/68 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
4.4%
3/68 • Number of events 3 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
|
Renal and urinary disorders
Renal and urinary disorders
|
2.9%
2/68 • Number of events 2 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
1.5%
1/68 • Number of events 1 • Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
|
Additional Information
Richard Philipson, MD Chief Medical Officer
Calliditas Therapeutics
Phone: +46 556659-9766
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60