Trial Outcomes & Findings for Prevention of Metabolic Complications of Glucocorticoid Excess (NCT NCT01319994)

NCT ID: NCT01319994

Last Updated: 2019-04-12

Results Overview

change in visceral/subcutaneous fat

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 57 participants
• Primary outcome timeframe: 3 months minus baseline
• Results posted on: 2019-04-12

Participant Flow

Patients were recruited into "Prevention" and "Treatment" algorithms initially. However, only the "Treatment" algorithm proved feasible for logistic reasons. Below are the results relating to patients randomized into the Treatment algorithm.

Participant milestones

Measure	Metformin Metformin 850mg TDS for 12 weeks	Placebo Placebo 850mg TDS for 12 weeks
Overall Study STARTED	26	27
Overall Study Abto Keep Appoinment Shedule	23	24
Overall Study Tolerated at Least 1.7g/Day Dose	19	24
Overall Study Glucocorticoid Dose as Inc Cri	19	22
Overall Study Did Not Develop Overt Diabetes	19	21
Overall Study COMPLETED	19	21
Overall Study NOT COMPLETED	7	6

Reasons for withdrawal

Measure	Metformin Metformin 850mg TDS for 12 weeks	Placebo Placebo 850mg TDS for 12 weeks
Overall Study Protocol Violation	7	6

Baseline Characteristics

Prevention of Metabolic Complications of Glucocorticoid Excess

Baseline characteristics by cohort

Measure	Metformin n=26 Participants Metformin 850mg TDS	Placebo n=27 Participants Placebo 850mg TDS	Total n=53 Participants Total of all reporting groups
Age, Continuous	47 years STANDARD_DEVIATION 15 • n=5 Participants	45 years STANDARD_DEVIATION 15 • n=7 Participants	46 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants	27 Participants n=7 Participants	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
visceral to subcutanous fat ratio	0.44 ratio n=5 Participants	0.58 ratio n=7 Participants	0.50 ratio n=5 Participants
HOMA2-IR	4.7 HOMA score n=5 Participants	4.2 HOMA score n=7 Participants	4.4 HOMA score n=5 Participants

PRIMARY outcome

Timeframe: 3 months minus baseline

change in visceral/subcutaneous fat

Outcome measures

Measure	Metformin n=19 Participants Metformin 850mg TDS	Placebo n=21 Participants Placebo 850mg TDS
CT Abdomen	0.08 ratio Standard Deviation 0.19	-0.03 ratio Standard Deviation 0.22

SECONDARY outcome

Timeframe: 3 months minus baseline

The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance and beta (β)-cell function. HOMA2-IR is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin resistance which is the reciprocal of insulin sensitivity (%S)(100/%S) as a percentage of a normal reference population (normal young adults). HOMA2-IR is calculated using the HOMA model: www.dtu.ox.ac.uk/homacalculator/

Outcome measures

Measure	Metformin n=19 Participants Metformin 850mg TDS	Placebo n=21 Participants Placebo 850mg TDS
HOMA2-IR	0.22 HOMA score Standard Deviation 3.26	2.35 HOMA score Standard Deviation 3.23

Adverse Events

Metformin

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

Placebo

Serious events: 9 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Measure	Metformin n=26 participants at risk Metformin 850mg TDS for 12 weeks	Placebo n=27 participants at risk Placebo 850mg TDS for 12 weeks
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/26 • 6 months adverse event definition is matching the definition of clinicaltrials.org	3.7% 1/27 • 6 months adverse event definition is matching the definition of clinicaltrials.org
Cardiac disorders Ischaemic heart disease	3.8% 1/26 • 6 months adverse event definition is matching the definition of clinicaltrials.org	0.00% 0/27 • 6 months adverse event definition is matching the definition of clinicaltrials.org
Gastrointestinal disorders Diverticulitis	0.00% 0/26 • 6 months adverse event definition is matching the definition of clinicaltrials.org	3.7% 1/27 • 6 months adverse event definition is matching the definition of clinicaltrials.org
Cardiac disorders Atypical chest pain	0.00% 0/26 • 6 months adverse event definition is matching the definition of clinicaltrials.org	3.7% 1/27 • 6 months adverse event definition is matching the definition of clinicaltrials.org
Vascular disorders Raynaud's	0.00% 0/26 • 6 months adverse event definition is matching the definition of clinicaltrials.org	3.7% 1/27 • 6 months adverse event definition is matching the definition of clinicaltrials.org
Endocrine disorders Severe osmotic symptoms	0.00% 0/26 • 6 months adverse event definition is matching the definition of clinicaltrials.org	7.4% 2/27 • 6 months adverse event definition is matching the definition of clinicaltrials.org
Respiratory, thoracic and mediastinal disorders Exacerbation of asthma	0.00% 0/26 • 6 months adverse event definition is matching the definition of clinicaltrials.org	11.1% 3/27 • 6 months adverse event definition is matching the definition of clinicaltrials.org

Other adverse events

Measure	Metformin n=26 participants at risk Metformin 850mg TDS for 12 weeks	Placebo n=27 participants at risk Placebo 850mg TDS for 12 weeks
Gastrointestinal disorders Gastrointestinal side-effects	61.5% 16/26 • 6 months adverse event definition is matching the definition of clinicaltrials.org	33.3% 9/27 • 6 months adverse event definition is matching the definition of clinicaltrials.org
General disorders Other	38.5% 10/26 • 6 months adverse event definition is matching the definition of clinicaltrials.org	66.7% 18/27 • 6 months adverse event definition is matching the definition of clinicaltrials.org

Additional Information

Prof M Korbonits

Queen Mary University of London

Phone: +442078826197

Email: m.korbonits@qmul.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place