Skip to content

Trial · Interventional

CompletedPhase 4Results postedRegistry data

Sitagliptin and Glucagon Counterregulation

Short name SITACLAMP

NCTNCT02256189 (opens ClinicalTrials.gov in a new tab)Other id300A
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures Glucagon, does not give it. It appears in an outcome measure.

Overview

Status
Completed
Phase
Phase 4
Enrollment
28 participants (actual)
Sponsor
Lund University · Other
Design
Randomized · Double masking
Countries
1 country

Sweden

Start
Apr 2015
Primary completion
Jun 2017
Completion
Jun 2017
First posted
3 Oct 2014 (estimated)
Last update posted
20 Feb 2019
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2015201620172018
  1. Ph 4

    SITACLAMP

    NCT02256189

    Apr 2015 to Jun 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

To evaluate the effect of DPP-4 inhibition on glucagon counter-regulatory mechanisms at moderate hypoglycemia in metformin-treated subjects with T2DM

Interventions

  • SitagliptinDrug
  • PlaceboDrug

Arms2

  • Other

    Sitagliptin first, then placebo

    Sitagliptin treatment for four weeks, then washout for four weeks, then placebo for four weeks

  • Other

    Placebo first, then sitagliptin

    Placebo for four weeks, then washout for four weeks, then sitagliptin for four weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Glucagon Counterregulation to Hypoglycemia

    Time frame · Four weeks treatment

    Registry description

    Change in plasma glucagon to insulin-induced hypoglycemia after four weeks of treatment with sitagliptin and placebo

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Four weeks treatment

Glucagon Counterregulation to Hypoglycemia

GroupValue (pmol/l)Spread
Sitagliptin16.02.9
Placebo16.52.8

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Sitagliptin First, Then PlaceboSitagliptin first for four weeks, then washout for four weeks, then placebo for four weeks0 / 150 / 150 / 15
Placebo First, Then StagliptinPlacebo first for four weeks, then washout for four weeks, then sitalgiptin for four weeks0 / 130 / 130 / 13
SitagliptinSitagliptin 100mg Daily for four weeks, either before or after a 4 week placebo period0 / 280 / 280 / 28
PlaceboPlacebo Daily for four weeks, efter before or after a 4 week sitagliptin period0 / 280 / 280 / 28

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 65 Years up to 90 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Written consent has been given. 2. Patients with metformin treated T2DM (metformin dose \>0,5 g/day and stable during the preceding 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 Exclusion Criteria: 1. A history of any secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly. 2. Type 2 diabetes, positive GAD antibodies 3. eGFR \<60 ml/min 4. Acute infections which may affect blood glucose control within 4 weeks prior to visit 1 5. Any history of recent (\<2 weeks) recurrent or severe hypoglycemic episodes. 6. Liver disease such as cirrhosis or chronic active hepatitis 7. History of coronary heart disease or heart failure class III or IV 8. Donation of one unit (500 ml) or more of blood, significant blood loss equaling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks. 9. Treatment with growth hormone of chronic oral or parenteral corticosteroid treatment (\> 7 consecutive days of treatment) within 8 weeks prior to visit 1. 10. Use of other investigational drugs at visit 1 or within 30 days of visit 1, unsuitable for the study

PepBank is a research reference. Talk to a doctor before you use any peptide.