DPP4inhibitors in Type 1 Diabetes

DPP4 inhibitors in Type 1 Diabetes - DPP4 inhibitors in Type 1 Diabetes Mellitus

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002407-18-GB

Enrollment

Registered

2012-07-10

Start date

2012-08-14

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Interventions

Trade Name: Onglyza Product Name: Saxagliptin Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Saxagliptin CAS Number: 361442-04-8 Concentration unit: mg milligram(s) Concentration type: e

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Type 1 diabetes with greater than 5 years disease duration ? HbA1C=65 years) yes F.1.3.1 Number of subjects for this age range 4

Exclusion criteria

Exclusion criteria: ? Previous history of pancreatic disease/cancer ? Significant renal disease eGFR <50 ? Personal/family history of Medullary thyroid cancer ? Personal/family history of MEN Type 2 ? Moderate/Severe hepatic impairment (Child Pugh B,C) ? Pregnancy/Breast feeding ? History of epilepsy/hypoglycaemia induced seizure ? Those on any other hypoglycaemic drug apart from insulin for their diabetes. ? Currently on CYP3A4 inducers like carbamazepine, dexamethasone, phenobarbital, phenytoin and rifampicin ? Currently on CYP3A4 inhibitors like ketoconazole, diltiazem

Design outcomes

Primary

Measure	Time frame
Main Objective: The body secretes hormones such as adrenaline as a response to low blood sugars. Patients who have had insulin dependant diabetes for over 5 years rely heavily on adrenaline release, to produce symptoms, so that they can respond appropriately to low blood sugars. However, this response is blunted in those with Type 1 diabetes. Our question is whether the degree of this response can be increased by use of 3 months of the DPP4inhibitor, so that patients become better aware of hypoglycaemia. ;Secondary Objective: Does DPPIVi used as an adjunct therapy to insulin, -improve glucose control -improve general health of the blood vessels -reduce weight? -reduce frequency of reported hypoglycaemia? -improve quality of life measures? ;Primary end point(s): Magnitude of adrenalin response at blood glucose of 2.5mmol/L;Timepoint(s) of evaluation of this end point: During the 2 clamp studies, when the blood glucose has reached 2.5mmol/L	—

Measure

Time frame

Main Objective: The body secretes hormones such as adrenaline as a response to low blood sugars. Patients who have had insulin dependant diabetes for over 5 years rely heavily on adrenaline release, to produce symptoms, so that they can respond appropriately to low blood sugars. However, this response is blunted in those with Type 1 diabetes. Our question is whether the degree of this response can be increased by use of 3 months of the DPP4inhibitor, so that patients become better aware of hypoglycaemia. ;Secondary Objective: Does DPPIVi used as an adjunct therapy to insulin, -improve glucose control -improve general health of the blood vessels -reduce weight? -reduce frequency of reported hypoglycaemia? -improve quality of life measures? ;Primary end point(s): Magnitude of adrenalin response at blood glucose of 2.5mmol/L;Timepoint(s) of evaluation of this end point: During the 2 clamp studies, when the blood glucose has reached 2.5mmol/L

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Secondary

Measure	Time frame
Secondary end point(s): HbA1C, Daily insulin requirements Glucose variability as assessed using the continuous glucose monitoring system. Hypoglycaemic awareness Lipid profile, BP, Vascular endothelial function Weight Frequency of hypoglycaemia Hospital Anxiety and Depression scale Fear of hypoglycaemia and Fear of Hyperglycaemia scale ;Timepoint(s) of evaluation of this end point: Baseline, then following each 3 month period of active treatment and then following 3 month period of placebo	—

Measure

Time frame

Secondary end point(s): HbA1C, Daily insulin requirements Glucose variability as assessed using the continuous glucose monitoring system. Hypoglycaemic awareness Lipid profile, BP, Vascular endothelial function Weight Frequency of hypoglycaemia Hospital Anxiety and Depression scale Fear of hypoglycaemia and Fear of Hyperglycaemia scale ;Timepoint(s) of evaluation of this end point: Baseline, then following each 3 month period of active treatment and then following 3 month period of placebo

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Countries

United Kingdom

Contacts

Public ContactPriya George

University of Dundeee

p.george@dundee.ac.uk01382 740507

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026