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Clinical Trials/NL-OMON41271
NL-OMON41271
Completed
Phase 4

A phase IV, randomized, double-blind, placebo-controlled, parallel-group trial to assess the effect of 12-week treatment with the glucagon-like peptide-1 receptor agonist (GLP-1RA) liraglutide or dipeptidyl peptidase-4 inhibitor (DPP-4i) sitagliptin on the cardiovascular, renal and gastrointestinal system in insulin-naïve patients with type 2 diabetes (T2DM). - SAFEGUARD, Pleiotropic effects of incretin based therapies

Vrije Universiteit Medisch Centrum0 sites70 target enrollmentTBD
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ConditionsType 2 Diabetes Mellitus10018424

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Type 2 Diabetes Mellitus
Sponsor
Vrije Universiteit Medisch Centrum
Enrollment
70
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- Both genders
  • •\-Age between 35 and 75 years. Females must be post\-menopausal (no menses \>1 year).
  • •\-Type 2 diabetes (HbA1c 6\.5\-9% DCCT or 48\-75 mmol/mol IFCC), who are being treated with a stable dose of oral antihyperglycemic agents (either metformin alone, SU alone or a combination of metformin and SU) for at least 3 months prior to inclusion.
  • •\-BMI 25 \- 40 kg/m2
  • •\- Caucasian;For the preceding pilot\-study:
  • •\- Age between 18 and 50 years
  • •\- BMI 25 \* 40 kg/m2
  • •\- Caucasian

Exclusion Criteria

  • •\- GFR \< 60 mL/min/1\.73m2
  • •\- Current / chronic use of the following medication: thiazolidinediones, GLP\-1RA, DPP\-4i, glucocorticoids, NSAIDs, insulin, antimicrobial agents, chemotherapeutics or immune suppressants. Subjects on diuretics will only be excluded when these drugs (e.g. hydrochlorothiazide) cannot be stopped for the duration of the study.
  • •\- History of or actual pancreatic disease or impaired pancreatic exocrine function (defined as needed use of pancreatic enzymes)
  • •\- Active liver disease or a 3\-fold elevation of liver enzymes (AST / ALT) at screening
  • •\- History of or actual malignancy (with the exception of basal cell carcinoma)
  • •\- Current urinary tract infection and active nephritis
  • •\-Recent (\<6 months) history of cardiovascular disease, including acute coronary syndrome, stroke, transient ischemic neurologic disorder or chronic heart failure (New York Heart Association grade II\-IV)
  • •\- Current atrial fibrillation
  • •\- Chronic infectious or auto\-immune disease
  • •\- Substance and/or alcohol abuse, defined as \>4 units alcohol/day (because of risk of pancreatitis)

Outcomes

Primary Outcomes

Not specified

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