DPP4inhibitors in Type 1 Diabetes

NCT01922817 | Completed Phase 3 DMC

• 1 other identifier: 2012DM07
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

A small, pilot, randomised, cross over trial that investigates the potential for DPPIVi therapy to reduce insulin requirements in type 1 diabetes was studied. We investigated whether this drug reduces daily insulin doses, leads to weight reduction, reduces blood glucose fluctuation and improves glucose control. Through reduction of blood glucose variability, we want investigated, whether it has the capability of improving the magnitude of epinephrine responses at 2.5mmol/L by performing a hyperinsulinaemic, hypoglycaemia clamp study after each arm. A successful outcome would then lead to an application for funds for a larger, multicentre intervention study. The benefits of this therapeutic advance are clear and this has the potential to make a dramatic improvement to the lives of people with type 1 diabetes in our community.

Conditions

Type 1 Diabetes; Hypoglycaemia

Outcome Measures

Primary Outcomes (1)

• Magnitude of epinephrine release at 2.5mmol/L

  During hyperinsulinaemic hypoglycaemia clamp

Study Arms (2)

Saxagliptin

ACTIVE COMPARATOR

5mg once daily in addition to insulin therapy

Drug: Saxagliptin

Placebo

PLACEBO COMPARATOR

Crossover Placebo once daily

Drug: Saxagliptin

Interventions

Saxagliptin DRUG

5mg saxagliptin

Placebo; Saxagliptin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 diabetes over 5 years duration
• HbA1c less than 10%
• Age 18 and over
• Current use of intensive insulin therapy (injections or pump)
• BMI 19-35
• Ability to give written informed consent to participate in the study

You may not qualify if:

• Previous history of pancreatic disease/cancer
• Significant renal disease estimated glomerular filtration rate (eGFR) less than 50
• Significant microvascular disease
• Personal/family history of Medullary thyroid cancer
• Personal/family history of multiple endocrine neoplasia (MEN) Type 2
• Moderate/Severe hepatic impairment
• Pregnancy or breast feeding
• History of epilepsy/hypoglycaemia induced seizure
• Those on any other hypoglycaemia drug apart from insulin for their diabetes.
• Currently on CYP3A4 inducers like carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampicin
• Currently on CYP3A4 inhibitors like ketoconazole, diltiazem
• Less than 30 days since participation in another drug trial or longer depending on the drug half life.

Sponsors & Collaborators

• University of Dundee: lead

Study Sites (1)

Clinical research centre, Ninewells Hospital and Medical School

Dundee, DD1 9SY, United Kingdom

Location

Related Publications (1)

• George PS, McCrimmon RJ. Saxagliptin co-therapy in C-peptide negative Type 1 diabetes does not improve counter-regulatory responses to hypoglycaemia. Diabet Med. 2016 Sep;33(9):1283-90. doi: 10.1111/dme.13046. Epub 2015 Dec 28.

  PMID: 26642301 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Interventions

saxagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blind
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: crossover trial between Saxaglipin and Placebo with 2 week washout in between

Study Record Dates

• First Submitted: August 6, 2013
• First Posted: August 14, 2013
• Study Start: September 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: October 15, 2019

Record last verified: 2019-10

Locations

GB (1)