Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart Twice Daily and Biphasic Insulin Aspart Twice Daily in Subjects With Type 2 Diabetes Mellitus Before, During and After Ramadan

December 20, 2017 updated by: Novo Nordisk A/S

A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart Twice Daily and Biphasic Insulin Aspart Twice Daily in Subjects With Type 2 Diabetes Mellitus Before, During and After Ramadan

This trial is conducted in Africa and Asia. The aim of this trial is to compare efficacy and safety of insulin degludec/insulin aspart twice daily and biphasic insulin aspart twice daily in subjects with type 2 diabetes mellitus before, during and after Ramadan.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

263

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Algeria
      • Algiers, Algeria
        • Novo Nordisk Investigational Site
      • Oran, Algeria, 31000
        • Novo Nordisk Investigational Site
      • Setif, Algeria, 19000
        • Novo Nordisk Investigational Site
      • Sidi Bel abbes, Algeria, 22000
        • Novo Nordisk Investigational Site
  • India
      • New Delhi, India, 110001
        • Novo Nordisk Investigational Site
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500 001
        • Novo Nordisk Investigational Site
      • Hyderabad, Andhra Pradesh, India, 500058
        • Novo Nordisk Investigational Site
    • Karnataka
      • Mysore, Karnataka, India, 570001
        • Novo Nordisk Investigational Site
    • Kerala
      • Kozhikode, Kerala, India, 673017
        • Novo Nordisk Investigational Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400058
        • Novo Nordisk Investigational Site
      • Mumbai, Maharashtra, India, 400010
        • Novo Nordisk Investigational Site
      • Pune, Maharashtra, India, 411001
        • Novo Nordisk Investigational Site
    • West Bengal
      • Kolkatta, West Bengal, India, 700073
        • Novo Nordisk Investigational Site
  • Lebanon
      • Beirut, Lebanon
        • Novo Nordisk Investigational Site
      • Hazmieh, Lebanon
        • Novo Nordisk Investigational Site
      • Lebanon - Beirut, Lebanon, 9611
        • Novo Nordisk Investigational Site
  • Malaysia
      • Cheras, Malaysia, 56000
        • Novo Nordisk Investigational Site
      • Kota Bharu, Kelantan, Malaysia, 16150
        • Novo Nordisk Investigational Site
      • Seremban, Negeri Sembilan, Malaysia, 70400
        • Novo Nordisk Investigational Site
  • South Africa
    • Gauteng
      • Benoni, Gauteng, South Africa, 1501
        • Novo Nordisk Investigational Site
      • Johannesburg, Gauteng, South Africa, 1827
        • Novo Nordisk Investigational Site
      • Johannesburg, Gauteng, South Africa, 1812
        • Novo Nordisk Investigational Site
      • Lenasia, Gauteng, South Africa, 1827
        • Novo Nordisk Investigational Site
      • Pretoria, Gauteng, South Africa, 0181
        • Novo Nordisk Investigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4091
        • Novo Nordisk Investigational Site
      • Durban, KwaZulu-Natal, South Africa, 4092
        • Novo Nordisk Investigational Site
      • Durban, KwaZulu-Natal, South Africa, 4450
        • Novo Nordisk Investigational Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7925
        • Novo Nordisk Investigational Site
  • United Arab Emirates
      • Ajman, United Arab Emirates, 4184
        • Novo Nordisk Investigational Site
      • Ajman, United Arab Emirates, 21499
        • Novo Nordisk Investigational Site
      • Dubai, United Arab Emirates, 7272
        • Novo Nordisk Investigational Site
      • Umm Al Quwain, United Arab Emirates, 24
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, age at least 18 years at the time of signing informed consent. Algeria: Male or female, age at least 19 years at the time of signing informed consent
  • Subjects diagnosed (clinically) with type 2 diabetes mellitus prior to day of screening (Visit 1)
  • Treated with any pre-mix/self-mix or basal insulin regimen for at least 90 days prior to the day of screening (Visit 1)
  • Subjects not on any OAD(s) (oral anti-diabetic drug) prior to trial participation OR subjects on fixed daily dose(s) of OAD(s) for at least 90 days prior to screening (Visit 1). The OAD(s) include any of the following anti-diabetic drug(s)/regimen: Biguanides (metformin equal to or above 1500 mg or maximum tolerated dose documented in the subject medical record) Insulin secretagogues (sulfonylureas (SU) and glinides), Dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors), a-glucosidase inhibitors, Sodium-glucose co-transporter 2- inhibitors (SGLT2 Inhibitors ) (above or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record)
  • HbA1c 7.0%-10.0% (53-86 mmol/mol) (both inclusive, by central laboratory analysis)
  • Intention to fast (daytime, i.e., between dawn and sunset) during Ramadan after receiving medical counselling regarding the risk of fasting
  • Willing to give blood during Ramadan

Exclusion Criteria:

  • Any contraindication for successful and sustained fasting from a medical perspective at the discretion of the investigator (such as acute illness, severe hypoglycaemia within 90 days prior to screening (Visit 1), hypoglycaemia unawareness, ketoacidosis within 90 days prior to screening (Visit), hyperosmolar hyperglycaemic coma within 90 days prior to screening (Visit 1), subjects performing intense physical labour)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IDegAsp U100 BID
Drug: insulin degludec/insulin aspart
Injected subcutaneously (s.c., under the skin)twice daily. The pre-trial insulin will be discontinued.
Active Comparator: BIAsp U100 BID
Drug: biphasic insulin aspart
Injected subcutaneously (s.c., under the skin)twice daily. The pre-trial insulin will be discontinued.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c (%) (Glycosylated Haemoglobin)
Time Frame: From week 0 to end of Ramadan (day 29 of Ramadan)
Mean change in HbA1c was evaluated from baseline (week 0) to end of Ramadan (day 29 of Ramadan).
From week 0 to end of Ramadan (day 29 of Ramadan)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fasting Plasma Glucose (FPG)
Time Frame: From week 0 to end of Ramadan (day 29 of Ramadan)
Mean change in FPG was evaluated from baseline (week 0) to end of Ramadan (day 29 of Ramadan).
From week 0 to end of Ramadan (day 29 of Ramadan)
Change in Fructosamine
Time Frame: From week 0 to end of Ramadan (day 29 of Ramadan)
Mean change in fructosamine was evaluated from baseline (week 0) to end of Ramadan (day 29 of Ramadan).
From week 0 to end of Ramadan (day 29 of Ramadan)
Number of Subjects Who Achieve HbA1c Below 7% (53 mmol/Mol (American Diabetes Association (ADA) Target )
Time Frame: End of Ramadan (day 29 of Ramadan)
Number of subjects who achieved HbA1c below 7% (53 mmol/mol; ADA target) at the end of Ramadan (day 29 of Ramadan).
End of Ramadan (day 29 of Ramadan)
Number of Subjects Who Achieve FPG Below or Equal to 7.2 mmol/L (ADA Target)
Time Frame: End of Ramadan (day 29 of Ramadan)
Number of subjects who achieved FPG <=7.2 mmol/L at the end of Ramadan (day 29 of Ramadan). The above written (in the endpoint title) 'ADA target' is not applicable for FPG.
End of Ramadan (day 29 of Ramadan)
Number of Treatment Emergent Hypoglycaemic Episodes Both According to the Novo Nordisk Definition for Hypoglycaemic Episodes (Severe or BG Hypoglycaemia) as Well as According to the ADA definition1 Confirmed Symptomatic
Time Frame: From week 0 to 4 weeks post Ramadan

Treatment-emergent hypoglycaemic episodes: If the onset of the episode occurred on or after the first day of investigational medicinal product (IMP; IDegAsp/BIAsp 30) administration, and no later than 1 day after the last day on IMP, before switching to or being treated with another insulin product.

The above mentioned definitions (in endpoint title) should read as the following:

Novo Nordisk definition; severe or blood glucose (BG) confirmed symptomatic hypoglycaemia: An episode that was severe according to ADA classification or BG confirmed by a plasma glucose (PG) value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.

American Diabetes Association (ADA) definition; documented symptomatic hypoglycaemia: An episode, during which typical symptoms of hypoglycaemia were accompanied by a measured PG concentration ≤3.9 mmol/L (70 mg/dL).

Due to character limitation, severe hypoglycaemia as per ADA classification is not defined here; see next outcome measure.
From week 0 to 4 weeks post Ramadan
Number of Treatment Emergent Nocturnal (00:01-05:59 am) Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Time Frame: From week 0 to 4 weeks post Ramadan

Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes, which occurred between 00:01 and 05:59 both inclusive.

Novo Nordisk definition; severe or blood glucose (BG) confirmed symptomatic hypoglycaemia: An episode that was severe according to ADA classification or BG confirmed by a plasma glucose (PG) value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.

Severe hypoglycaemia as per ADA classification: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.
From week 0 to 4 weeks post Ramadan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2016

Primary Completion (Actual)

September 4, 2016

Study Completion (Actual)

September 5, 2016

Study Registration Dates

First Submitted

January 5, 2016

First Submitted That Met QC Criteria

January 5, 2016

First Posted (Estimate)

January 6, 2016

Study Record Updates

Last Update Posted (Actual)

September 11, 2018

Last Update Submitted That Met QC Criteria

December 20, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN5401-4243
  • U1111-1170-8304 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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