← Trials/Trial dossier/NCT05390307

OTID

CompletedPhase NA

Obesity Treatment to Improve Diabetes

Lead sponsor

Dasman Diabetes Institute

Assets

Liraglutide / Semaglutide

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Chronic kidney disease, Obesity / overweight, Type 1 diabetes

Key I/E criterion

•BMI ≥25

Primary endpoint

•Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05390307

Org study IDRA-HM2021009

Timeline

Milestones

Study first posted2022-05-25actual

Study start2023-04-01actual

Primary completion2024-01-01actual

Study completion2024-01-01actual

Last update posted2024-02-28actual

Assets

Investigational agents

Liraglutide Semaglutide

Study populations

Who this study enrolls

Chronic kidney diseaseObesity / overweightType 1 diabetes

Eligibility

Who can enroll

Minimum age21 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

To be considered eligible to participate in this study, a patient must:

•Be aged between 21-65 years,

•Have a BMI ≥ 25 kg/m2,

•Have established diagnosis of Type 1 Diabetes for at least 1 year before screening visit

•Insulin treatment for T1D - may be either via any FDA approved insulin pump (CSII) for at least 6 months prior to screening visit or via multiple daily insulin injections. All participants must be stable on insulin doses/ regimen for at least 3 months

•Have established diagnosis of Chronic Kidney Disease stage 1-4

•Able to give informed consent

Exclusion criteria

Participants will be excluded if:

•Have been treated with GLP-1 or SGLT2i within the last 3 months and/or have a history of GLP1RA or SGLT2i intolerance

•Diagnosis of T2D or any other type of diabetes (other than type 1)

•Treatment with anti-obesity drugs within 12 weeks prior to randomisation

•Significant changes in the lifestyle (Diet or exercise pattern in within 3 months of the screening visit)

•Any self reported changes (gain or loss) in body weight >5% within 3 months of screening visit

•eGFR ≤15 mL/min/1.73m2

•Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using or willing to use adequate contraceptive methods during the study period

•Experienced diabetic ketoacidosis within 6 months of screening visit

•Experienced sever hypoglycaemia within 6 months of screening visit

•Any of the following laboratory values at screening (liver chemistry > 3X upper limit of normal, high Tg (. 5.7 mmol/L)

•Have terminal illness or are not primarily responsible for their own care

•Any other significant disease or disorder which in the opinion of the investigator, may either put the participants at risk or may influence the result of the study or the participant's ability to participate

•Untreated or uncontrolled hypothyroidism/hyperthyroidism defined as thyroid-stimulating hormone >6 mIU/litre or <0.4 mIU/litre

•Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)

•Personal history of non-familial medullary thyroid carcinoma

•History of chronic pancreatitis or idiopathic acute pancreatitis

•Amylase levels three times higher than the upper normal range

•Obesity induced by other endocrinologic disorders (e.g. Cushing's Syndrome)

•Current or history of treatment with medications that may cause significant weight gain, within 12 weeks prior to randomisation, including systemic corticosteroids (except for a short course of treatment, i.e. 7-10 days), atypical antipsychotic and mood stabilizers (e.g. clozapine, olanzapine, valproic acid and its derivatives, and lithium)

•Initiation of antidepressants during the last 12 weeks

•Previous surgical treatment for obesity (excluding liposuction if performed >1 year before trial entry)

•History of other severe psychiatric disorders

•History of known or suspected abuse of alcohol and/or narcotics

•History of major depressive episode during the last 2 years

•Simultaneous participation in other clinical trials of investigational drugs, lifestyle or physical activity interventions. Patients will only be able to take part following participation in a previous clinical trial after a wash-out period of 16 weeks.

•History of dementia or cognitive impairment

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Cardiometabolic biomarkers

Glycemic / diabetes

Renal / kidney

Weight & body composition

3 endpoints

Primary/protocol endpoint

Weight

Time frame:26 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Waist circumference

Time frame:26 weeks

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Weight change

Time frame:26 weeks

threshold achievement, improvement

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Glycaemia

Time frame:26 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Renal / kidney

1 endpoint

Secondary/protocol endpoint

Albuminuria

Time frame:26 weeks

uACR, change

change from baseline, improvement

LOINC 9318-7

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Hypertension

Time frame:26 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Lipidaemia

Time frame:26 weeks

change from baseline, improvement

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Combining glucagon-like peptide 1 analogues with sodium-glucose cotransporter 2 inhibitors to treat patients with type 1 diabetes, BMI > 25 kg/m(2), and chronic kidney disease - A randomised, controlled pilot study.
Diabetes research and clinical practice2026 Jan (month)PMID41435968doi:10.1016/j.diabres.2025.113066via pubmed nct search
Obesity Treatments to Improve Type 1 Diabetes (OTID): a randomized controlled trial of the combination of glucagon-like peptide 1 analogues and sodium-glucose cotransporter 2 inhibitors-protocol for Obesity Treatments to Improve Type 1 Diabetes (the OTID trial).
Trials2024 Feb 16PMID38365744doi:10.1186/s13063-024-07930-3via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.