Trial Outcomes & Findings for Efficacy of Pioglitazone on Bone Metabolism in Postmenopausal Women With Impaired Fasting Glucose. (NCT NCT00708175)

NCT ID: NCT00708175

Last Updated: 2012-02-03

Results Overview

The change in bone mineral density in the total proximal femur at month 12 relative to baseline. DXA is a means of measuring BMD through x-ray.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 156 participants
• Primary outcome timeframe: Baseline and Month 12.
• Results posted on: 2012-02-03

Participant Flow

Participants took part in the study at 25 investigative sites in the United States from 23 May 2008 to 02 February 2011.

Postmenopausal participants enrolled in 1 of 2 treatment groups to examine the effect of pioglitazone on bone mineral density (BMD) by dual-energy-ray absorptiometry (DXA). Participants with >7% decrease from baseline in BMD of the total proximal femur or spine based on DXA scan results (confirmed with a repeat scan) were to discontinue study drug.

Participant milestones

Measure	Pioglitazone Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.	Placebo Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
Overall Study STARTED	78	78
Overall Study COMPLETED	60	57
Overall Study NOT COMPLETED	18	21

Reasons for withdrawal

Measure	Pioglitazone Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.	Placebo Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
Overall Study Adverse Event	4	5
Overall Study Protocol Violation	2	3
Overall Study Lost to Follow-up	5	3
Overall Study Withdrawal by Subject	5	7
Overall Study BMD loss >7%	2	3

Baseline Characteristics

Efficacy of Pioglitazone on Bone Metabolism in Postmenopausal Women With Impaired Fasting Glucose.

Baseline characteristics by cohort

Measure	Pioglitazone n=78 Participants Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.	Placebo n=78 Participants Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.	Total n=156 Participants Total of all reporting groups
Age Continuous	59.0 years STANDARD_DEVIATION 5.04 • n=93 Participants	60.2 years STANDARD_DEVIATION 6.17 • n=4 Participants	59.6 years STANDARD_DEVIATION 5.65 • n=27 Participants
Age, Customized <45 years	0 participants n=93 Participants	1 participants n=4 Participants	1 participants n=27 Participants
Age, Customized Between 45 and 64 years	66 participants n=93 Participants	54 participants n=4 Participants	120 participants n=27 Participants
Age, Customized ≥65 years	12 participants n=93 Participants	23 participants n=4 Participants	35 participants n=27 Participants
Sex: Female, Male Female	78 Participants n=93 Participants	78 Participants n=4 Participants	156 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 participants n=93 Participants	0 participants n=4 Participants	1 participants n=27 Participants
Race (NIH/OMB) Asian	2 participants n=93 Participants	4 participants n=4 Participants	6 participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants
Race (NIH/OMB) Black or African American	6 participants n=93 Participants	6 participants n=4 Participants	12 participants n=27 Participants
Race (NIH/OMB) White	70 participants n=93 Participants	68 participants n=4 Participants	138 participants n=27 Participants
Race (NIH/OMB) More than one race	1 participants n=93 Participants	0 participants n=4 Participants	1 participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants
Region of Enrollment United States	78 participants n=93 Participants	78 participants n=4 Participants	156 participants n=27 Participants
Ethnicity Hispanic or Latino	38 participants n=93 Participants	34 participants n=4 Participants	72 participants n=27 Participants
Ethnicity Non Hispanic or Latino	40 participants n=93 Participants	44 participants n=4 Participants	84 participants n=27 Participants
Height	160.3 cm STANDARD_DEVIATION 6.85 • n=93 Participants	161.1 cm STANDARD_DEVIATION 7.70 • n=4 Participants	160.7 cm STANDARD_DEVIATION 7.28 • n=27 Participants
Weight	76.03 kg STANDARD_DEVIATION 13.406 • n=93 Participants	79.02 kg STANDARD_DEVIATION 16.326 • n=4 Participants	77.53 kg STANDARD_DEVIATION 14.964 • n=27 Participants
Body Mass Index (BMI)	29.61 kg/m2 STANDARD_DEVIATION 5.055 • n=93 Participants	30.29 kg/m2 STANDARD_DEVIATION 4.872 • n=4 Participants	29.95 kg/m2 STANDARD_DEVIATION 4.960 • n=27 Participants
Smoking Classification Never smoked	52 participants n=93 Participants	55 participants n=4 Participants	107 participants n=27 Participants
Smoking Classification Current smoker	7 participants n=93 Participants	9 participants n=4 Participants	16 participants n=27 Participants
Smoking Classification Ex-smoker	19 participants n=93 Participants	14 participants n=4 Participants	33 participants n=27 Participants
History of hip fracture? Yes	5 participants n=93 Participants	3 participants n=4 Participants	8 participants n=27 Participants
History of hip fracture? No	73 participants n=93 Participants	75 participants n=4 Participants	148 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and Month 12.

Population: All randomized participants who received at least 1 dose of study medication (Full Analysis Set). This was an observed case analysis with no imputation for missing data. If a valid pre-treatment scan was not available, the earliest (within 30 days) post-dosing scan was used as Baseline. There was one such participant for this endpoint.

The change in bone mineral density in the total proximal femur at month 12 relative to baseline. DXA is a means of measuring BMD through x-ray.

Outcome measures

Measure	Pioglitazone n=58 Participants Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.	Placebo n=61 Participants Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
Percent Change From Baseline to Month 12 in Bone Mineral Density in the Total Proximal Femur by Dual-Energy-Ray Absorptiometry (DXA)	-0.69 percent Standard Error 0.284	-0.14 percent Standard Error 0.277

SECONDARY outcome

Timeframe: Month 12 and Month 18.

Population: All randomized participants who received at least 1 dose of study medication (Full Analysis Set). This was an observed case analysis with no imputation for missing data.

The change in bone mineral density in the total proximal femur at month 18 relative to month 12. DXA is a means of measuring BMD through x-ray.

Outcome measures

Measure	Pioglitazone n=53 Participants Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.	Placebo n=56 Participants Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
Percent Change From Month 12 to Month 18 in Bone Mineral Density in the Total Proximal Femur by DXA	-0.14 percent Standard Error 0.265	0.04 percent Standard Error 0.258

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Month 12; Month 12 and Month 18.

Population: All randomized participants who received at least 1 dose of study medication (Full Analysis Set).

The change between the fasting plasma glucose value collected at each time frame indicated.

Outcome measures

Measure	Pioglitazone n=78 Participants Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.	Placebo n=78 Participants Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
Change in Fasting Plasma Glucose (FPG) Baseline to Month 12 (n=57; n=61)	-2.8 mg/dL Standard Error 1.66	6.0 mg/dL Standard Error 1.61
Change in Fasting Plasma Glucose (FPG) Month 12 to Month 18 (n=54; n=57)	0.4 mg/dL Standard Error 2.00	-1.0 mg/dL Standard Error 1.94

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 18 months.

Population: All randomized participants who received at least 1 dose of study medication (Full Analysis Set).

Participants were considered to have converted to T2DM if there were ≥2 consecutive post-Baseline FPG measurements ≥126 mg/dL. Participants meeting criteria were tabulated and summarized by Study Period (Treatment and Follow-up). Conversion to T2DM during Treatment Period occurred if either both of the consecutive post-Baseline high FPG values, or the first of the 2 consecutive high values occurred on or before the first day off study drug. Conversion to T2DM occurred during the Follow-up Period if both consecutive high values occurred after at least 1 day after the Treatment Period.

Outcome measures

Measure	Pioglitazone n=78 Participants Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.	Placebo n=78 Participants Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
Number of Participants Who Converted to Type 2 Diabetes Mellitus (T2DM) Double-Blind Period (n=76; n=75)	1 participants 1.3	7 participants 9.3
Number of Participants Who Converted to Type 2 Diabetes Mellitus (T2DM) Follow-up Period (n=63; n=59)	0 participants 0.0	1 participants 1.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 18 months.

Population: All randomized participants who received at least 1 dose of study medication (Full Analysis Set).

Number of participants with confirmed (through an adjudication process) fractures during the study. Circumstances surrounding the fracture, available X-ray and other diagnostic results and healing status were collected for the adjudication process.

Outcome measures

Measure	Pioglitazone n=78 Participants Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.	Placebo n=78 Participants Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
Number of Participants With Fracture	1 participants	3 participants

Adverse Events

Pioglitazone

Serious events: 3 serious events

Other events: 32 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pioglitazone n=78 participants at risk Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.	Placebo n=78 participants at risk Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
Cardiac disorders Cardiac failure congestive	1.3% 1/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Diverticulitis	1.3% 1/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Peridiverticular abscess	1.3% 1/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Tracheobronchitis	0.00% 0/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.3% 1/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Subdural haematoma	1.3% 1/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Migraine	1.3% 1/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Renal and urinary disorders Calculus urinary	0.00% 0/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.3% 1/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Other adverse events

Measure	Pioglitazone n=78 participants at risk Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks.	Placebo n=78 participants at risk Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.
Infections and infestations Urinary tract infection	7.7% 6/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	12.8% 10/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
General disorders Oedema peripheral	11.5% 9/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.6% 2/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	7.7% 6/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.1% 4/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Sinusitis	0.00% 0/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	7.7% 6/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Musculoskeletal and connective tissue disorders Back pain	5.1% 4/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	6.4% 5/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Respiratory, thoracic and mediastinal disorders Cough	6.4% 5/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	0.00% 0/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood glucose increased	1.3% 1/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.1% 4/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Blood parathyroid hormone increased	5.1% 4/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.3% 1/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Injury, poisoning and procedural complications Fall	2.6% 2/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.1% 4/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Nervous system disorders Headache	2.6% 2/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.1% 4/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Infections and infestations Influenza	0.00% 0/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	5.1% 4/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Gastrointestinal disorders Nausea	5.1% 4/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	2.6% 2/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Investigations Weight increased	5.1% 4/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.	1.3% 1/78 • Treatment-emergent serious adverse events are serious adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Additional Information

Sr. VP, Clinical Science

Takeda Global Research and Development Center, Inc.

Phone: 800-778-2860

Email: clinicaltrialregistry@tpna.com

Results disclosure agreements

• Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
• Publication restrictions are in place

Restriction type: OTHER