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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02648217
• Other study ID #: NN5401-4243
• Secondary ID: U1111-1170-8304
• Status: Completed
• Phase: Phase 3
• Start date: January 4, 2016
• Est. completion date: September 5, 2016

Study information

• Verified date: December 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: September 5, 2016
• Est. primary completion date: September 4, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin degludec/insulin aspart
Injected subcutaneously (s.c., under the skin)twice daily. The pre-trial insulin will be discontinued.
• biphasic insulin aspart
Injected subcutaneously (s.c., under the skin)twice daily. The pre-trial insulin will be discontinued.

Locations

Country	Name	City	State
Algeria	Novo Nordisk Investigational Site	Algiers
Algeria	Novo Nordisk Investigational Site	Oran
Algeria	Novo Nordisk Investigational Site	Setif
Algeria	Novo Nordisk Investigational Site	Sidi Bel abbes
India	Novo Nordisk Investigational Site	Hyderabad	Andhra Pradesh
India	Novo Nordisk Investigational Site	Hyderabad	Andhra Pradesh
India	Novo Nordisk Investigational Site	Kolkatta	West Bengal
India	Novo Nordisk Investigational Site	Kozhikode	Kerala
India	Novo Nordisk Investigational Site	Mumbai	Maharashtra
India	Novo Nordisk Investigational Site	Mumbai	Maharashtra
India	Novo Nordisk Investigational Site	Mysore	Karnataka
India	Novo Nordisk Investigational Site	New Delhi
India	Novo Nordisk Investigational Site	Pune	Maharashtra
Lebanon	Novo Nordisk Investigational Site	Beirut
Lebanon	Novo Nordisk Investigational Site	Hazmieh
Lebanon	Novo Nordisk Investigational Site	Lebanon - Beirut
Malaysia	Novo Nordisk Investigational Site	Cheras
Malaysia	Novo Nordisk Investigational Site	Kota Bharu, Kelantan
Malaysia	Novo Nordisk Investigational Site	Seremban, Negeri Sembilan
South Africa	Novo Nordisk Investigational Site	Benoni	Gauteng
South Africa	Novo Nordisk Investigational Site	Cape Town	Western Cape
South Africa	Novo Nordisk Investigational Site	Durban	KwaZulu-Natal
South Africa	Novo Nordisk Investigational Site	Durban	KwaZulu-Natal
South Africa	Novo Nordisk Investigational Site	Durban	KwaZulu-Natal
South Africa	Novo Nordisk Investigational Site	Johannesburg	Gauteng
South Africa	Novo Nordisk Investigational Site	Johannesburg	Gauteng
South Africa	Novo Nordisk Investigational Site	Lenasia	Gauteng
South Africa	Novo Nordisk Investigational Site	Pretoria	Gauteng
United Arab Emirates	Novo Nordisk Investigational Site	Ajman
United Arab Emirates	Novo Nordisk Investigational Site	Ajman
United Arab Emirates	Novo Nordisk Investigational Site	Dubai
United Arab Emirates	Novo Nordisk Investigational Site	Umm Al Quwain

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Algeria,  India,  Lebanon,  Malaysia,  South Africa,  United Arab Emirates, 

References & Publications (1)

Hassanein M, Echtay AS, Malek R, Omar M, Shaikh SS, Ekelund M, Kaplan K, Kamaruddin NA. Original paper: Efficacy and safety analysis of insulin degludec/insulin aspart compared with biphasic insulin aspart 30: A phase 3, multicentre, international, open-l — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c (%) (Glycosylated Haemoglobin)	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	Change in Fasting Plasma Glucose (FPG)	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)
Secondary	Change in Fructosamine	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)
Secondary	Number of Subjects Who Achieve HbA1c Below 7% (53 mmol/Mol (American Diabetes Association (ADA) Target )	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)
Secondary	Number of Subjects Who Achieve FPG Below or Equal to 7.2 mmol/L (ADA Target)	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)
Secondary	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	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
Secondary	Number of Treatment Emergent Nocturnal (00:01-05:59 am) Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes	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

External Links

•   Clinical Trials at Novo Nordisk