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Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes and Moderate Renal Impairment (PIONEER 5)

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ClinicalTrials.gov Identifier: NCT02827708
Recruitment Status : Completed
First Posted : July 11, 2016
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of oral semaglutide versus placebo in subjects with type 2 diabetes and moderate renal impairment.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: semaglutide Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes and Moderate Renal Impairment
Actual Study Start Date : September 20, 2016
Actual Primary Completion Date : May 15, 2018
Actual Study Completion Date : May 15, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arm Intervention/treatment
Experimental: Semaglutide Drug: semaglutide
Oral administration once daily.

Placebo Comparator: Placebo Drug: placebo
Oral administration once daily.




Primary Outcome Measures :
  1. Change in glycosylated haemoglobin (HbA1c) [ Time Frame: Week 0, Week 26 ]

Secondary Outcome Measures :
  1. Change in body weight (kg) [ Time Frame: Week 0, Week 26 ]
  2. Change in fasting plasma glucose [ Time Frame: Week 0, Week 26 ]
  3. HbA1c below 7.0% [ Time Frame: At week 26 ]
  4. Number of treatment-emergent adverse events [ Time Frame: Weeks 0-31 ]
  5. Number of treatment-emergent severe or blood glucose-confirmed symptomatic hypoglycaemic episodes [ Time Frame: Weeks 0-31 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
  • Male or female, age above or equal to 18 years at the time of signing informed consent
  • Diagnosed with type 2 diabetes mellitus for at least 90 days prior to day of screening
  • HbA1c (glycosylated haemoglobin) of 7.0-9.5% (53-80 mmol/mol) (both inclusive)
  • Moderate renal impairment defined as estimated glomerular filtration rate of 30-59 mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula
  • Stable daily dose(s) within 90 days prior to the day of screening of any of the following treatment regimens:- 1-2 of the following oral anti-diabetic drugs: - Metformin equal or above 1500 mg or maximum tolerated dose documented in the subject medical record), - Sulfonylurea (equal or above half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record) - Basal insulin alone (20% change in total daily dose of insulin glargine, insulin detemir, insulin degludec or NPH insulin) or - Metformin (equal or above 1500 mg or maximum tolerated dose documented in the subject medical record) in combination with basal insulin (20% change in total daily dose of insulin glargine, insulin detemir, insulin degludec or NPH insulin)

Exclusion Criteria:

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice).For certain specific countries: Additional specific requirements apply
  • Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
  • Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma
  • History of pancreatitis (acute or chronic)
  • History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
  • Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening and randomisation
  • Subjects presently classified as being in New York Heart Association Class IV
  • Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
  • Subjects with alanine aminotransferase above 2.5 x upper normal limit
  • Rapidly progressing renal disease (e.g. such as acute glomerulonephritis) as judged by the investigator or known nephrotic albuminuria (above 2200 mg/24 hours or above 2200 mg/g)
  • Use of systemic immunosuppressive treatment within 90 days prior to screening
  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening. An exception is short-term insulin treatment for acute illness for a total of below or equal to 14 days
  • Known hypoglycaemic unawareness and/or recurrent severe hypoglycaemic episodes as judged by the investigator
  • Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation
  • History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02827708


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Sponsors and Collaborators
Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02827708     History of Changes
Other Study ID Numbers: NN9924-4234
2015-005326-19 ( EudraCT Number )
U1111-1176-9230 ( Other Identifier: WHO )
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases