Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00611884
First received: January 29, 2008
Last updated: October 16, 2015
Last verified: October 2015
Results First Received: October 16, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Diabetes
Diabetes Mellitus, Type 2
Interventions: Drug: insulin glargine
Drug: insulin degludec
Drug: metformin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
There were 28 sites: Canada (4), India (4), South Africa (3) and the United States of America (17).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects underwent a run-in period of 3 weeks; 2 weeks of up-titration period, where metformin was up-titrated to 1500 or 2000 mg/day, followed by 1 week of maintenance period. Subjects who tolerated 1500 or 2000 mg/day of metformin for a week and had a median fasting plasma glucose ≥ 7.5 mmol/L (135 mg/dL) were randomised.

Reporting Groups
  Description
SIBA (D) Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
SIBA (E) Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
SIBA (D) M, W, F Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
IGlar Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.

Participant Flow:   Overall Study
    SIBA (D)     SIBA (E)     SIBA (D) M, W, F     IGlar  
STARTED     61     60     62     62  
Exposed     58 [1]   59 [2]   61 [2]   61 [2]
COMPLETED     52     51     58     56  
NOT COMPLETED     9     9     4     6  
Adverse Event                 1                 0                 0                 1  
Non-Compliance                 1                 4                 2                 2  
Lack of Efficacy                 0                 1                 0                 0  
Unclassified                 7                 4                 2                 3  
[1] Three subjects withdrew prior to exposure to trial drug
[2] One subject withdrew prior to exposure to trial drug



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
SIBA (D) Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
SIBA (E) Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
SIBA (D) M, W, F Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
IGlar Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
Total Total of all reporting groups

Baseline Measures
    SIBA (D)     SIBA (E)     SIBA (D) M, W, F     IGlar     Total  
Number of Participants  
[units: participants]
  61     60     62     62     245  
Age  
[units: years]
Mean (Standard Deviation)
  53.9  (8.5)     55.3  (8.7)     54.4  (8.8)     53.1  (10.2)     54.2  (9.1)  
Gender  
[units: participants]
         
Female     22     27     34     25     108  
Male     39     33     28     37     137  
Glycosylated haemoglobin (HbA1c)  
[units: percentage¬†of¬†glycosylated¬†haemoglobin]
Mean (Standard Deviation)
  8.7  (1.1)     8.6  (1.2)     8.8  (1.1)     8.7  (1.1)     8.7  (1.1)  
Fasting plasma glucose (FPG)  
[units: mmol/L]
Mean (Standard Deviation)
  10.6  (3.6)     9.9  (3.2)     10.6  (3.4)     9.8  (3.1)     10.2  (3.4)  



  Outcome Measures
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1.  Primary:   Change in Glycosylated Haemoglobin (HbA1c)   [ Time Frame: Week 0, Week 16 ]

2.  Secondary:   Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)   [ Time Frame: Week 16 ]

3.  Secondary:   Rate of Major and Minor Hypoglycaemic Episodes   [ Time Frame: Week 0 to Week 16 + 5 days follow up ]

4.  Secondary:   Rate of Nocturnal Major and Minor Hypoglycaemic Episodes   [ Time Frame: Week 0 to Week 16 + 5 days follow up ]

5.  Secondary:   Rate of Treatment Emergent Adverse Events (AEs)   [ Time Frame: Week 0 to Week 16 + 5 days follow up ]

6.  Secondary:   Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)   [ Time Frame: Week -4, Week 16 ]

7.  Secondary:   Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)   [ Time Frame: Week -4, Week 16 ]

8.  Secondary:   Laboratory Safety Parameters (Biochemistry): Serum Creatinine   [ Time Frame: Week -4, Week 16 ]

9.  Secondary:   Vital Signs: Diastolic Blood Pressure (BP)   [ Time Frame: Week 0, Week 16 ]

10.  Secondary:   Vital Signs: Systolic Blood Pressure (BP)   [ Time Frame: Week 0, Week 16 ]

11.  Secondary:   Vital Signs: Pulse   [ Time Frame: Week 0, Week 16 ]

12.  Secondary:   Physical Examination   [ Time Frame: Week -4, Week 0, Week 8, Week 16 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
e-mail: clinicaltrials@novonordisk.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00611884     History of Changes
Other Study ID Numbers: NN1250-1836
Study First Received: January 29, 2008
Results First Received: October 16, 2015
Last Updated: October 16, 2015
Health Authority: India: Ministry of Health
South Africa: Medicines Control Council
United States: Food and Drug Administration
Canada: Health Canada