NCT00836225 is a Phase 1 clinical trial of ISIS 388626 in Type 2 Diabetes Mellitus, sponsored by Ionis Pharmaceuticals, Inc..

Who is sponsoring NCT00836225?

NCT00836225 is sponsored by Ionis Pharmaceuticals, Inc..

What drugs are being tested in NCT00836225?

Interventions in NCT00836225: ISIS 388626.

What condition does NCT00836225 study?

NCT00836225 studies Type 2 Diabetes Mellitus.

Is NCT00836225 still recruiting?

NCT00836225 is currently completed. Last updated 2 February 2012.

Last reviewed 2012-02-02 · How we verify

NCT00836225

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase I , Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ISIS 388626 Administered to Healthy Volunteers

Completed Phase 1 Last updated 2 February 2012

What this trial tests

Phase 1 trial testing ISIS 388626 in Type 2 Diabetes Mellitus in 103 participants. Completed in 1 January 2012.

Timeline

1 January 2009

Primary endpoint
1 October 2011

1 January 2012

Quick facts

Lead sponsor	Ionis Pharmaceuticals, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	103
Start date	1 January 2009
Primary completion	1 October 2011
Estimated completion	1 January 2012
Sites	1 location across Netherlands

Drugs / interventions tested

ISIS 388626 — full drug profile →

Conditions studied

Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →

Sponsor

Ionis Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 18 to 65, any sex, with Type 2 Diabetes Mellitus. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

To evaluate the safety and tolerability of single and multiple doses of ISIS-SGLT2Rx administered subcutaneously
Time frame: 30 days for single dose, 11 weeks for 6-week dosing, 18 weeks for 13-week dosing

Sponsor's own description

The primary purpose of this trial is to assess the safety and tolerability of ISIS-SGLT2Rx when given at increasing single doses and to assess the safety and tolerability of the same doses when given multiple times.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Efficacy, safety and regulatory status of SGLT2 inhibitors: focus on canagliflozin.
Haas B, Eckstein N, Pfeifer V, Mayer P, et al · · 2014 · cited 77× · PMID 25365416 · DOI 10.1038/nutd.2014.40
RNA-Based Therapies in Kidney Diseases.
Hu L, Jin T, Zhang N, Ding J, et al · · 2025 · cited 4× · PMID 40059951 · DOI 10.2147/jir.s505252
Treating the Untreatable: Antisense Oligonucleotides as an Individualized Therapy for Rare Genetic Kidney Diseases.
Tekendo-Ngongang C, Gleeson JG, Mignon L. · · 2024 · cited 1× · PMID 39331470 · DOI 10.1681/asn.0000000532
Antisense Oligonucleotides: Technological Advances, Clinical Progress, and Expanding Therapeutic Frontiers.
Xu L, Zhang H, Jiang B, Jiang Y, et al · · 2026 · PMID 42076098 · DOI 10.3390/pharmaceutics18040446

Verify or expand the search:

Other recruiting trials for Type 2 Diabetes Mellitus

Currently open trials in the same condition.

NCT07351058 — A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight and Type 2 Diabetes · Phase 3 · recruiting
NCT07373938 — Carotid Wall Texture as a Cardiovascular Risk Biomarker in Type 2 Diabetes Mellitus · recruiting
NCT07433062 — A Study to Evaluate the Effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants With · Phase 1 · recruiting
NCT07276776 — An Evaluation of the Omnipod® M System in Adults With Type 2 Diabetes · NA · active not recruiting
NCT07232537 — An Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic · recruiting

Other Ionis Pharmaceuticals, Inc. trials

Trials by the same sponsor.

NCT06673069 — Hero: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) and Pharmacodynamics (PD) of ION269 in Par · Phase 1 · terminated
NCT06014541 — Observational Study to Characterize Biomarkers and Disease Progression in Participants With Methyl CpG Binding Protein 2 · terminated
NCT05610280 — A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, · Phase 3 · completed
NCT05579860 — A Study Comparing Two Subcutaneous Formulations: Vial and Autoinjector (AI) With Olezarsen, at Two Dose Levels, in Healt · Phase 1 · completed
NCT05552326 — A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00836225 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ionis Pharmaceuticals, Inc.
Last refreshed: 2 February 2012

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00836225.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing