Study of the counter-regulation to hypoglycemia during treatment with sitagliptin in subjects with type 2 diabetes

The Effect of Sitagliptin on Glucagon Dynamics and Incretin Hormones During Mild Hypoglycemia in Elderly Patients with Metformin-Treated Type 2 Diabetes - SITACLAMP

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002685-70-SE

Enrollment

Unknown

Registered

2014-08-18

Start date

2015-08-03

Completion date

Unknown

Last updated

2017-05-22

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

Conditions

Type 2 Diabetes Mellitus

Interventions

Product Name: Sitagliptin Product Code: A10BH01 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Sitagliptin CAS Number: 654671-77-9 Concentration unit: mg milligram(s) Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Written consent has been given. 2. Patients with metformin treated T2DM (metformin dose >=0.5/day and stable during the preceeding 3 months) 3. Age >=65 years. 4. HbA1c 6.0-8.5% (43-67 mmol/mol; inclusive) at visit 1. 5. Ability to complete the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 28

Exclusion criteria

Exclusion criteria: 1. Use of other glucose-lowering therapy than metformin within three months prior to visit 1. 2. A history of any secondary forms of diabetes, e.g., Cushing’s syndrome and acromegaly. 3. Type 2 diabetes, positive GAD antibodies 4. eGFR 7 consecutive days of treatment) within 8 weeks prior to visit 1. 13. Use of other investigational drugs at visit 1 or within 30 days of visit 1, unsuitable for the study 14. Hypersensitivity to sitagliptin or any compound in the tablet core (microcrystalline cellulose (E460), calcium hydrogen phosphate, anhydrous (E341), croscarmellose sodium (E468), magnesium stearate (E470b) or sodium stearyl fumarate) or in the film coating (poly(vinyl alcohol), macrogol (E3350), talc (E553b), titanium dioxide (E171), red iron oxide (E172) or yellow iron oxide (E172))

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess if sitagliptin can improve the glucagon secretory response to mild hypoglycemia in elderly patients with metformin-treated type 2 diabetes.;Secondary Objective: To assess if sitagliptin can improve the cotisol, eipnephrine, norepinephrine and glucose counterregulatory responses to mild hypoglycemia in edlerly patients with metformin-treated T2DM.;Primary end point(s): The effect of sitagliptin on glucagon counter-regulation to hypoglycemia measured as ?glucagon (min 165-135) and ?glucagon (min 195-165);Timepoint(s) of evaluation of this end point: 4 weeks	—

Measure

Time frame

Main Objective: To assess if sitagliptin can improve the glucagon secretory response to mild hypoglycemia in elderly patients with metformin-treated type 2 diabetes.;Secondary Objective: To assess if sitagliptin can improve the cotisol, eipnephrine, norepinephrine and glucose counterregulatory responses to mild hypoglycemia in edlerly patients with metformin-treated T2DM.;Primary end point(s): The effect of sitagliptin on glucagon counter-regulation to hypoglycemia measured as ?glucagon (min 165-135) and ?glucagon (min 195-165);Timepoint(s) of evaluation of this end point: 4 weeks

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Secondary

Measure	Time frame
Secondary end point(s): 1. The effect of sitagliptin compared to placebo on the counter-regulatory hormones cortisol, epinephrine and norepinephrine at the hypoglycemic clamp steps, determined as ? for these variables min 165-135 and 195-165, respectively, 2- The effect of sitagliptin compared to placebo on the insulin secretory rate estimated from the C-peptide responses and GLP-1 and GIP levels at the hypoglycemic clamp steps determined as ? for these variables min 165-135 and 195-165, respectively. ;Timepoint(s) of evaluation of this end point: 4 weeks	—

Measure

Time frame

Secondary end point(s): 1. The effect of sitagliptin compared to placebo on the counter-regulatory hormones cortisol, epinephrine and norepinephrine at the hypoglycemic clamp steps, determined as ? for these variables min 165-135 and 195-165, respectively, 2- The effect of sitagliptin compared to placebo on the insulin secretory rate estimated from the C-peptide responses and GLP-1 and GIP levels at the hypoglycemic clamp steps determined as ? for these variables min 165-135 and 195-165, respectively. ;Timepoint(s) of evaluation of this end point: 4 weeks

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Countries

Sweden

Contacts

Public ContactClinical Research Department

Skane University Hospital

Margaretha.M.Persson@skane.se4640332037

Outcome results

None listed

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