NCT01272583

Brief Summary

Hypoglycaemia is a well-known complication of insulin treated diabetes. The counterregulatory response to hypoglycaemia, with glucagon as the most important mediator, is initially diminished within a few years of onset of Type 1 diabetes and subsequently lost and thus increasing the risk of hypoglycaemia. Dipeptidyl Peptidase (DPP)-4 inhibitors augment the glucagon response to insulin-induced hypoglycaemia in type 2 diabetes. The investigators hypothesize that treatment with a DPP-4 inhibitor in patients with type 1 diabetes will recover the alpha cell response to hypoglycaemia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 10, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 17, 2014

Completed
Last Updated

March 14, 2014

Status Verified

February 1, 2014

Enrollment Period

1.3 years

First QC Date

January 5, 2011

Results QC Date

October 15, 2013

Last Update Submit

February 14, 2014

Conditions

Type 1 DiabetesHypoglycemia

Keywords

Type 1 diabetesDPP-4 inhibitorGlucagon

Outcome Measures

Primary Outcomes (2)

  • Glucagon Response to Acute Hypoglycaemia

    Change in glucagon concentration from the initialisation phase to 40 minutes after occurrence of the autonomic reaction to hypoglycaemia

    Change from initialisation phase to 40 minutes after onset of hypoglycaemia

  • Glucagon Response to Acute Hypoglycaemia

    Area under the curve (AUC) from onset of the autonomic response to hypoglycaemia to 40 minutes after onset of the autonomic response. AUC values were calculated by the trapezoid method.

    0, 10, 20 and 40 minutes

Secondary Outcomes (6)

  • Intact and Total Glucagon Like Peptide-1 (GLP-1), Intact and Total Gastric Inhibitory Peptide (GIP) Response to Acute Hypoglycaemia

    0, 10, 20, 40 minutes

  • Epinephrine Response to Acute Hypoglycaemia

    0, 10, 20, 40 minutes

  • Norepinephrine Response to Acute Hypoglycaemia

    0, 10, 20, 40 minutes

  • Growth Hormone Response to Acute Hypoglycaemia

    0, 10, 20, 40 minutes

  • Cortisol Response to Acute Hypoglycaemia

    0, 10, 20, 40 minutes

  • +1 more secondary outcomes

Study Arms (2)

Sequence A (sitagliptin→placebo)

OTHER

Cross-over, both arms reveived the same intervention in different order.

Drug: SitagliptinDrug: Placebo

Sequence B (placebo→sitagliptin)

OTHER

Cross-over, both arms reveived the same intervention in different order.

Drug: SitagliptinDrug: Placebo

Interventions

SitagliptinDRUG

100 mg once daily for six weeks

Also known as: Januvia
Sequence A (sitagliptin→placebo)Sequence B (placebo→sitagliptin)
PlaceboDRUG

placebo, once daily for six weeks

Sequence A (sitagliptin→placebo)Sequence B (placebo→sitagliptin)

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Type 1 Diabetes Mellitus 5-20 years duration
  • C-peptide negative
  • Willing and able to give written informed consent

You may not qualify if:

  • Impaired awareness of hypoglycaemia
  • BMI \> 27 kg/m2
  • Evidence of severe diabetes complications (autonomic neuropathy, macroalbuminuria, proliferative retinopathy)
  • Acute illness within 3 months before the study
  • Significant renal impairment (creatinine clearance \< 50ml/min)
  • Use of beta-adrenoreceptor blockers
  • Cardiac history (previous arrhythmia)
  • History of epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Medical Center

Amsterdam, North Holland, 1100DD, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Hypoglycemia

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Results Point of Contact

Title
Dr. Josefine E. Schopman
Organization
Academic Medical Center
j.e.schopman@amc.uva.nl
+31 20 5669111

Study Officials

  • Frits Holleman, MD,PhD

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, MD

Study Record Dates

First Submitted

January 5, 2011

First Posted

January 10, 2011

Study Start

March 1, 2011

Primary Completion

June 1, 2012

Study Completion

October 1, 2012

Last Updated

March 14, 2014

Results First Posted

February 17, 2014

Record last verified: 2014-02

Locations

NL(1)