Observational Study on the Effect of NovoMix® 30, Levemir® or NovoRapid® (Alone or Combined) in Type 2 Diabetics Previously Treated With Anti-diabetic Medication

Diabetes Mellitus, Type 2 Clinical Trial

— A1chieve®  

Official title:

The Effect of NovoMix® 30, Levemir® or NovoRapid® (Alone or in Combination) in Subjects With Type 2 Diabetes Previously Treated With Other Anti-diabetic Medication. A 24-week, International, Prospective, Multi-centre, Open-labelled, Non-interventional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00869908
• Other study ID #: INS-3693
• Status: Completed
• Phase: N/A
• First received: March 23, 2009
• Last updated: January 18, 2017
• Start date: November 2008
• Est. completion date: March 2011

Study information

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

Clinical Trial Summary

This study is conducted in Africa, Asia, South America and Europe. The aim of this observational study is to document the experience with the study insulins when used in routine clinical practice. After the physician's decision to start insulin treatment using NovoMix® 30, Levemir® or NovoRapid® (alone or combined), type 2 diabetics will be eligible to be included in this study at the physician's discretion

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66726
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• After the physician has taken the decision to use NovoMix®30, Levemir® or NovoRapid® (alone or combined), any subject with type 2 diabetes who is not treated with these insulins or who has started on these insulin within the last 4 weeks before inclusion into this study is eligible for the study.

• The selection of the subjects will be at the discretion of the individual physician.

Exclusion Criteria:

• Subjects treated with NovoMix® 30, Levemir® or NovoRapid® (alone or in combination) for more than 4 weeks before inclusion into this study.

• Subjects who were previously enrolled in this study.

• Subjects with a hypersensitivity to NovoMix® 30, Levemir® or NovoRapid® or to any of the excipients.

• Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 6 months.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin aspart
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
• insulin detemir
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
• biphasic insulin aspart
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Locations

Country	Name	City	State
Algeria	Novo Nordisk Investigational Site	Algiers
Argentina	Novo Nordisk Investigational Site	Prov. de Buenos Aires
Bangladesh	Novo Nordisk Investigational Site	Dhaka
China	Novo Nordisk Investigational Site	Beijing	Beijing
Egypt	Novo Nordisk Investigational Site	Cairo
India	Novo Nordisk Investigational Site	Bangalore
Indonesia	Novo Nordisk Investigational Site	Jakarta
Iran, Islamic Republic of	Novo Nordisk Investigational Site	Teheran
Jordan	Novo Nordisk Investigational Site	Amman
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Libyan Arab Jamahiriya	Novo Nordisk Investigational Site	Tripoli
Malaysia	Novo Nordisk Investigational Site	Selangor Darul Ehsan
Mexico	Novo Nordisk Investigational Site	Mexico City
Morocco	Novo Nordisk Investigational Site	Casablanca
Pakistan	Novo Nordisk Investigational Site	Karachi
Philippines	Novo Nordisk Investigational Site	Manilla
Russian Federation	Novo Nordisk Investigational Site	Moscow
Saudi Arabia	Novo Nordisk Investigational Site	Riyadh
Singapore	Novo Nordisk Investigational Site	Singapore
Taiwan	Novo Nordisk Investigational Site	Taipei
Tunisia	Novo Nordisk Investigational Site	Tunisia
Turkey	Novo Nordisk Investigational Site	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Algeria,  Argentina,  Bangladesh,  China,  Egypt,  India,  Indonesia,  Iran, Islamic Republic of,  Jordan,  Korea, Republic of,  Libyan Arab Jamahiriya,  Malaysia,  Mexico,  Morocco,  Pakistan,  Philippines,  Russian Federation,  Saudi Arabia,  Singapore,  Taiwan,  Tunisia,  Turkey, 

References & Publications (15)

Chen L, Xing X, Lei M, Liu J, Shi Y, Li P, Qin G, Li C, Li Y, Wang Q, Gao T, Hu L, Wang Y, Yang W. Biphasic insulin aspart 30 improved glycemic control in Chinese patients with type 2 diabetes poorly controlled on oral glucose-lowering drugs: a subgroup a — View Citation

El Naggar NK, Soewondo P, Khamseh ME, Chen JW, Haddad J. Switching from biphasic human insulin 30 to biphasic insulin aspart 30 in type 2 diabetes is associated with improved glycaemic control and a positive safety profile: results from the A1chieve study — View Citation

El-Naggar N, Almansari A, Khudada K, Salman S, Mariswamy N, Abdelfattah W, Hashim F. The A1 chieve study - an observational non-interventional study of patients with type 2 diabetes mellitus initiating or switched to insulin analogue therapy: subgroup ana — View Citation

Home P, Naggar NE, Khamseh M, Gonzalez-Galvez G, Shen C, Chakkarwar P, Wenying Y. An observational non-interventional study of people with diabetes beginning or changed to insulin analogue therapy in non-Western countries: the A1chieve study. Diabetes Res — View Citation

Home PD, Latif ZA, González-Gálvez G, Prusty V, Hussein Z. The effectiveness and safety of beginning insulin aspart together with basal insulin in people with type 2 diabetes in non-Western nations: results from the A1chieve observational study. Diabetes — View Citation

Home PD, Shen C, Hasan MI, Latif ZA, Chen JW, González Gálvez G. Predictive and explanatory factors of change in HbA1c in a 24-week observational study of 66,726 people with type 2 diabetes starting insulin analogs. Diabetes Care. 2014;37(5):1237-45. doi: — View Citation

Hwang YC, Kang JG, Ahn KJ, Cha BS, Ihm SH, Lee S, Kim M, Lee BW. The glycemic efficacies of insulin analogue regimens according to baseline glycemic status in Korean patients with type 2 diabetes: sub-analysis from the A(1)chieve(®) study. Int J Clin Prac — View Citation

Khamseh ME, Haddad J, Yang W, Zilov A, Bech OM, Hasan MI. Safety and effectiveness of biphasic insulin aspart 30 in different age-groups: a1chieve sub-analysis. Diabetes Ther. 2013 Dec;4(2):347-61. doi: 10.1007/s13300-013-0033-z. — View Citation

Litwak L, Goh SY, Hussein Z, Malek R, Prusty V, Khamseh ME. Prevalence of diabetes complications in people with type 2 diabetes mellitus and its association with baseline characteristics in the multinational A1chieve study. Diabetol Metab Syndr. 2013 Oct — View Citation

Randeree H, Liebl A, Hajjaji I, Khamseh M, Zajdenverg L, Chen JW, Haddad J. Safety and effectiveness of bolus insulin aspart in people with type 2 diabetes: a1chieve sub-analysis. Diabetes Ther. 2013 Jun;4(1):153-66. doi: 10.1007/s13300-013-0026-y. — View Citation

Shah S, Yang W, Hasan MI, Malek R, Molskov Bech O, Home P. Biphasic insulin aspart 30 in insulin-naive people with type 2 diabetes in non-western nations: results from a regional comparative multinational observational study (A(1)chieve). Diabetes Technol — View Citation

Shah S, Zilov A, Malek R, Soewondo P, Bech O, Litwak L. Improvements in quality of life associated with insulin analogue therapies in people with type 2 diabetes: results from the A1chieve observational study. Diabetes Res Clin Pract. 2011 Dec;94(3):364-7 — View Citation

Shah SN, Litwak L, Haddad J, Chakkarwar PN, Hajjaji I. The A1chieve study: a 60 000-person, global, prospective, observational study of basal, meal-time, and biphasic insulin analogs in daily clinical practice. Diabetes Res Clin Pract. 2010 May;88 Suppl 1 — View Citation

Yang W, Zhuang X, Li Y, Wang Q, Bian R, Shen J, Hammerby E, Yang L. Improvements in quality of life associated with biphasic insulin aspart 30 in type 2 diabetes patients in China: results from the A1chieve® observational study. Health Qual Life Outcomes. — View Citation

Zilov A, El Naggar N, Shah S, Shen C, Haddad J. Insulin detemir in the management of type 2 diabetes in non-Western countries: safety and effectiveness data from the A1chieve observational study. Diabetes Res Clin Pract. 2013 Sep;101(3):317-25. doi: 10.10 — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of serious adverse drug reactions and major hypoglycaemic events reported as serious adverse drug reactions		at baseline, 12 weeks and 24 weeks
Secondary	Evaluate the prescribing patterns and choice of insulin analogues in routine clinical practice		at baseline, 12 weeks and 24 weeks
Secondary	Change in number of hypoglycaemic events		at baseline, 12 weeks and 24 weeks
Secondary	Change in HbA1c		at baseline, 12 weeks and 24 weeks
Secondary	Change in FPG (Fasting Plasma Glucose)		at baseline, 12 weeks and 24 weeks
Secondary	Change in PPG (postprandial glucose)		at baseline, 12 weeks and 24 weeks

External Links

•   Clinical Trials at Novo Nordisk