Efficacy and Safety of Inhaled Pre-prandial Human Insulin in Type 2 Diabetes

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Terminated

CT.gov ID

NCT00348712

Collaborator

(none)

301

Enrollment

Locations

Arms

16.2

Actual Duration (Months)

4.1

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial is conducted in Europe.

The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to metformin compared to adding rosiglitazone to metformin for the treatment of type 2 diabetes and to verify its safety (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).

Condition or Disease	Intervention/Treatment	Phase
Diabetes Diabetes Mellitus, Type 2	Drug: rosiglitazone Drug: inhaled human insulin Drug: metformin	Phase 3

Detailed Description

The decision to discontinue the development of AERx® is not due to any safety concerns. An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Study Design

Study Type:

Interventional

Actual Enrollment :

301 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of Inhaled Pre-prandial Human Insulin Plus Metformin Versus Rosiglitazone Plus Metformin in Type 2 Diabetes

Actual Study Start Date :

Oct 30, 2006

Actual Primary Completion Date :

Mar 5, 2008

Actual Study Completion Date :

Mar 5, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A	Drug: inhaled human insulin Treat-to-target dose titration scheme, inhalation. Other Names: NN1998 Drug: metformin Tablets, 2000 mg/day.
Active Comparator: B	Drug: rosiglitazone Tablets, 4 mg once or twice daily. Drug: metformin Tablets, 2000 mg/day.

Arm

Intervention/Treatment

Active Comparator: A

Drug: inhaled human insulin

Treat-to-target dose titration scheme, inhalation.

Other Names:

NN1998

Drug: metformin

Tablets, 2000 mg/day.

Active Comparator: B

Drug: rosiglitazone

Tablets, 4 mg once or twice daily.

Drug: metformin

Tablets, 2000 mg/day.

Outcome Measures

Primary Outcome Measures

Treatment difference in HbA1c [After 26 weeks]

Secondary Outcome Measures

Adverse events [For the duration of the trial]
Body weight [For the duration of the trial]
Lung function [For the duration of the trial]
Blood glucose [For the duration of the trial]
Hypoglycaemia [For the duration of the trial]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Type 2 diabetes
Treated with OAD(s) for more than or equal to 2 months
Body mass index of (BMI) less than or equal to 40.0 kg/m2
HbA1c greater than or equal to 7.5% and less than or equal to 11.0 % for subjects in OAD monotherapy and HbA1c greater than or equal to 7.0% and less than or equal to 10.0 % for subjects on OAD combination therapy

Exclusion Criteria:

Recurrent major hypoglycaemia
Current smoking or smoking within the last 6 months
Impaired hepatic or renal function
Cardiac disorders
Uncontrolled hypertension
Proliferative retinopathy or maculopathy

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Novo Nordisk Investigational Site	Ebreichsdorf	Austria	2483
2	Novo Nordisk Investigational Site	Wien	Austria	1030
3	Novo Nordisk Investigational Site	Wien	Austria	1090
4	Novo Nordisk Investigational Site	Joensuu	Finland	80130
5	Novo Nordisk Investigational Site	Kirkkonummi	Finland	02400
6	Novo Nordisk Investigational Site	Turku	Finland	FI-20520
7	Novo Nordisk Investigational Site	Corbeil Essonnes	France	91106
8	Novo Nordisk Investigational Site	LA ROCHELLE cedex	France	17019
9	Novo Nordisk Investigational Site	Mougins	France	06250
10	Novo Nordisk Investigational Site	Nanterre	France	92014
11	Novo Nordisk Investigational Site	Narbonne	France	11108
12	Novo Nordisk Investigational Site	NEVERS cedex	France	58033
13	Novo Nordisk Investigational Site	Pessac	France	33600
14	Novo Nordisk Investigational Site	Pointe à Pitre	France	97159
15	Novo Nordisk Investigational Site	Roubaix	France	59100
16	Novo Nordisk Investigational Site	Tours	France	37044
17	Novo Nordisk Investigational Site	Venissieux	France	69200
18	Novo Nordisk Investigational Site	Aschaffenburg	Germany	63739
19	Novo Nordisk Investigational Site	Augsburg	Germany	86150
20	Novo Nordisk Investigational Site	Bad Mergentheim	Germany	97980
21	Novo Nordisk Investigational Site	Berlin	Germany	13355
22	Novo Nordisk Investigational Site	Darmstadt	Germany	64283
23	Novo Nordisk Investigational Site	Dormagen	Germany	41539
24	Novo Nordisk Investigational Site	Dresden	Germany	01307
25	Novo Nordisk Investigational Site	Duisburg	Germany	47051
26	Novo Nordisk Investigational Site	Flörsheim	Germany	65439
27	Novo Nordisk Investigational Site	Frankfurt	Germany	60590
28	Novo Nordisk Investigational Site	Fulda	Germany	36037
29	Novo Nordisk Investigational Site	Genthin	Germany	39307
30	Novo Nordisk Investigational Site	Hermaringen	Germany	89568
31	Novo Nordisk Investigational Site	Kutenholz-Mulsum	Germany	27449
32	Novo Nordisk Investigational Site	Münster	Germany	48145
33	Novo Nordisk Investigational Site	Pirna	Germany	01796
34	Novo Nordisk Investigational Site	Schkeuditz	Germany	04435
35	Novo Nordisk Investigational Site	Wangen	Germany	88239
36	Novo Nordisk Investigational Site	Wiesbaden	Germany	65191
37	Novo Nordisk Investigational Site	Dublin	Ireland	DUBLIN 7
38	Novo Nordisk Investigational Site	Dublin	Ireland	DUBLIN 8
39	Novo Nordisk Investigational Site	Waterford	Ireland
40	Novo Nordisk Investigational Site	Delft	Netherlands	2625 AD
41	Novo Nordisk Investigational Site	Den Haag	Netherlands	2582 LJ
42	Novo Nordisk Investigational Site	Den Haag	Netherlands	2597 AX
43	Novo Nordisk Investigational Site	Drachten	Netherlands	9202 NN
44	Novo Nordisk Investigational Site	Rijswijk	Netherlands	2281 AK
45	Novo Nordisk Investigational Site	Roelofarendsveen	Netherlands	2371 RB
46	Novo Nordisk Investigational Site	Vlodrop	Netherlands	6063 DA
47	Novo Nordisk Investigational Site	Zwijndrecht	Netherlands	3331 LZ
48	Novo Nordisk Investigational Site	Alcira	Spain	46600
49	Novo Nordisk Investigational Site	Barcelona	Spain	08035
50	Novo Nordisk Investigational Site	Gijón	Spain	33206
51	Novo Nordisk Investigational Site	Majadahonda	Spain	28222
52	Novo Nordisk Investigational Site	Palma de Mallorca	Spain	07010
53	Novo Nordisk Investigational Site	Partida de Bacarot	Spain	03114
54	Novo Nordisk Investigational Site	Pontevedra	Spain	36071
55	Novo Nordisk Investigational Site	Reus	Spain	43201
56	Novo Nordisk Investigational Site	San Juan	Spain	03550
57	Novo Nordisk Investigational Site	Sevilla	Spain	41009
58	Novo Nordisk Investigational Site	Interlaken-Unterseen	Switzerland	3800
59	Novo Nordisk Investigational Site	Olten	Switzerland	4600
60	Novo Nordisk Investigational Site	Zürich	Switzerland	8032
61	Novo Nordisk Investigational Site	Aberdeen	United Kingdom	AB25 1LD
62	Novo Nordisk Investigational Site	Bath	United Kingdom	BA1 2SR
63	Novo Nordisk Investigational Site	Belfast	United Kingdom	BT12 6BA
64	Novo Nordisk Investigational Site	Birmingham	United Kingdom	B9 5SS
65	Novo Nordisk Investigational Site	Bradford-on-Avon	United Kingdom	BA15 1DQ
66	Novo Nordisk Investigational Site	Guildford	United Kingdom	GU2 7XX
67	Novo Nordisk Investigational Site	Hull	United Kingdom	HU3 2JZ
68	Novo Nordisk Investigational Site	Northampton	United Kingdom	NN1 5BD
69	Novo Nordisk Investigational Site	Salford	United Kingdom	M6 8HD
70	Novo Nordisk Investigational Site	Swansea	United Kingdom	SA6 6NL
71	Novo Nordisk Investigational Site	Trowbridge	United Kingdom	BA14 8QA
72	Novo Nordisk Investigational Site	Trowbridge	United Kingdom	BA14 9AR
73	Novo Nordisk Investigational Site	Wirral, Merseyside	United Kingdom	CH63 4JY
74	Novo Nordisk Investigational Site	York	United Kingdom	YO3 7HE